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    Anleger ohne langen Atem - VICAL - 500 Beiträge pro Seite

    eröffnet am 23.08.08 17:40:54 von
    neuester Beitrag 29.06.14 17:09:13 von
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     Ja Nein
      Avatar
      schrieb am 23.08.08 17:40:54
      Beitrag Nr. 1 ()
      Guten Tag, :kiss:

      mich überrascht immer wieder, wenn in unseren Foren ein antizyklischer Ansatz diskutiert wird, aber nicht in die Praxis umgesetzt wird. Bei diesem Pionier der Entwicklung eines gentechnisch erzeugten Krebsbekämpfungswirkstoffs hat es seit Beginn der 90ger Jahre keine nennenswerten Rückstände gegeben und mehrere Pharmaunternehmen sind an Bord. Die Biotech-Enthusiasten haben sich bis vor einigen Jahren über diesen Wert heißdiskutiert, als noch einige Unsicherheiten zu umschiffen waren, aber jetzt, wo die Erntezeit kurz bevor steht und die Aktie zum zweifachen Buchwert zu haben ist (Price to Tangible Book - MRQ 2.29) bleiben die Privatanleger weg.

      Neben den monokonalen Antikörpern (passive Immuntherapie mittels Gardasil und Cervarix welche 2007 von GSK und SanofiAventis auf den Markt gebracht wurden) befinden sich ein paar Dutzend von klassischen Impftechnologien (aktive Immuntherapie) zur Behandlung von Krebs in Forschungspipelines diverser Labore. In diesen Projekten werden dem Patienten spezifische Krebsantigene (Proteine) oder inaktivierte Tumorzellen mit dem Ziel verabreicht, das körpereigene Immunsystem zu stimulieren und in die Tumorabwehr einzubinden. Konkret bedeutet dies, dass man versucht, das Immunsystem zu aktivieren, so dass die Krebsantigene als "fremd" bzw. "schädlich" erkannt werden. Anschliessend machen sich Immunzellen auf die Suche im menschlichen Körper, um gleiche Strukturen zu finden und zu eliminieren. Beobachtet man die weltweite Forschungs- und Entwicklungstätigkeit im Zusammenhang mit aktiven Immunotherapien gegen Krebs, so fallen zwar um die siebzig Projekte auf, die sich in der klinischen Entwicklung befinden. Betrachtet man jedoch deren Entwicklungsstadium, trennt sich die Spreu vom Weizen, denn an deren Spitze als weit fortgeschrittene Phase III-Projekte liegen allein die Wirkstoffe GV1001 von Pharmexa A/S, GVAX von Cell Genesys Inc., Sipuleucel-T von Dendreon Corp. und Allovectin-7 von Vical.

      Der Impfansatz von Vical (Allovectin-7) benutzt Plasmid-DNA, welche die Sequenzen für wichtige Immunsystem-stimulierende Moleküle enthalten. Die direkte Injektion der Plasmid-Lösung in den Tumor führt dazu, dass die Krebserkrankung vom Immunsystem besser eingegrenzt und angegangen wird.

      Der Chart der Aktie von Vical löst beim Charttechniker wohl wenig Freude aus, aber er lässt das Herz eines fundamental orientierten Investors mit antizyklischem Ansatz höher schlagen:



      Ich denke, allein die "Wiederentdeckung" dieses Biotech-Unternehmens durch Privatinvestoren würde dem Kurs einen Schub auf einen angemessenen Wert von über sechs Dollar verleihen. Ich bin seit dieser Woche investiert und werde einen langen Atem haben.

      Herzliche Grüße
      sistra
      Avatar
      schrieb am 23.08.08 18:55:26
      Beitrag Nr. 2 ()
      Antwort auf Beitrag Nr.: 34.827.242 von sistra am 23.08.08 17:40:54ich bin auch schon ein weilchen investiert,aber der kursverlauf ist einfach schrecklich:cry::cry::cry::cry:
      es geht nur runter und das mit minimalen umsätzen
      Avatar
      schrieb am 23.08.08 22:45:08
      Beitrag Nr. 3 ()
      Antwort auf Beitrag Nr.: 34.827.876 von asics01 am 23.08.08 18:55:26
      ich bin auch schon ein weilchen investiert ...

      Hallo asics01!

      Wenn das "Weilchen" ein Kauf in diesem Jahr war, ist vergleichsweise wenig passiert. "Nur runter" wäre dann eher der gefühlte Kursverlauf, denn so heftig war die Abwärtsbewegung nicht. Von Herbst 2002 bis Anfang 2003 gab es auch an einigen Tagen die Gelegenheit, sich für unter 3,00 USD/Aktie bei Vical einzukaufen. Allzu dramatisch ist der Kursverlauf also eher nicht. Vielleicht eher schon als langweilig zu empfinden, doch das sollte sich ändern. Seit Herbst 2002 wurden erhebliche Fortschritte gemacht, die sich im Kursverlauf nicht widerspiegeln.

      Gruß sistra
      Avatar
      schrieb am 24.08.08 08:01:16
      Beitrag Nr. 4 ()
      Antwort auf Beitrag Nr.: 34.829.551 von sistra am 23.08.08 22:45:08wenn ALLOVECTIN 7 scheitern sollte,bzw schlechte studienergebnisse kommen sollten was meinst du wo vical dann aufschlägt:cry::cry:
      aber bei positiven news (hatten wir in letzter zeit auch,nur der kurs sprang nicht an,bzw wurde gleich wieder runtergeprügelt)könnte vical auch explodieren.
      alles in allem wie bei allen bios ein investment chance 50/50
      hopp oder topp.
      asics
      Avatar
      schrieb am 24.08.08 13:05:56
      Beitrag Nr. 5 ()
      Antwort auf Beitrag Nr.: 34.832.834 von asics01 am 24.08.08 08:01:16
      Hallo asics01,

      nein, in diesem Fall ist die Chance höher als 50:50, nachdem die japanische AnGes MG zu für Vical sehr attraktiven Konditionen aufgesprungen ist. AnGes MG ist nicht ein beliebiger weltweit operierender Pharmakonzern, der sich mit Risikokapital und Knebelverträgen als Geldgeber an interessante Entwicklungen dranhängt, sondern ein Unternehmen, das aus der universitären Forschung auf genau diesem Gebiet hervorgegangen ist. Die japanische Genforschung genießt ohnehin den weltweit besten Ruf und AnGes MG ist im Bereich der aktiven Immuntherapie in der Weltspitze.

      Wenn AnGes MG nun im Juni 2007 seine Phase-3-Studien in Japan für einen Wirkstoff mit einem vergleichbaren Wirkungsprinzip erfolgreich beendet hat (siehe http://www.anges-mg.com/en/news/pdf/070614.pdf) und sich in Kenntnis seiner eigenen Forschung bereits im Mai 2006 eine Beteiligung an der Entwicklung von Vical's Allovectin zu für Vical attraktiven Konditionen sichert, ist dies mehr als ein Vertrauensbeweis. Abgesehen von der Finanzierung mit bis zu 100 Mio. USD behält Vical die exklusiven Vermarktungsrechte für Allovectin in den Vereinigten Staaten und dem Rest der Welt außerhalb spezifizierter Länder in Asien (natürlich allen voran Japan) Ländern, für die die AnGes ausschließliche Rechte bekommen hat.

      Der Rest der Pipeline ist bei Vical übrigens auch größer als bei so manchem derzeit euphorisch betrachteten Biotechunternehmen.

      Herzliche Grüße
      sistra

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      Avatar
      schrieb am 24.08.08 17:25:59
      Beitrag Nr. 6 ()
      Antwort auf Beitrag Nr.: 34.835.005 von sistra am 24.08.08 13:05:56das was du hir schreibst ist mir auch bekannt,aber ein restrisiko bleibt immer.ich bin schon mit so vielen bios baden gegangen wo es auch keiner für möglich hielt dass sie scheitern.
      aber gerade wegen der geschichte mit ANGES und der pipline bin ich auch bei vical eingestiegen.
      asics
      Avatar
      schrieb am 24.08.08 20:54:09
      Beitrag Nr. 7 ()
      Ich bin auch investiert, und zwar seit Februar 2008 mit einer kleinen Position von nicht ganz 3% meines Aktiendepotwertes. Im Gegensatz zu Asics hat mir die Beobachtung des Kursverlaufs keinen Angstschweiß auf die Stirn getrieben. Vical ist immerhin der Pionier seiner Zunft. Die Investition sehe ich ganz gelassen, ganz im Sinne der Ironie im Threadtitel.
      Avatar
      schrieb am 25.08.08 12:55:31
      Beitrag Nr. 8 ()
      :rolleyes:
      Avatar
      schrieb am 25.08.08 18:46:04
      Beitrag Nr. 9 ()
      Antwort auf Beitrag Nr.: 34.846.724 von invest2002 am 25.08.08 12:55:31
      :rolleyes: = -----> Lesezeichen <----- ?
      Avatar
      schrieb am 25.08.08 20:38:24
      Beitrag Nr. 10 ()
      Antwort auf Beitrag Nr.: 34.838.199 von Biobrandschutz am 24.08.08 20:54:09[i]Im Gegensatz zu Asics hat mir die Beobachtung des Kursverlaufs keinen Angstschweiß auf die Stirn getrieben[/i]
      wie kommst du den dadrauf ??bist du ein seher???;):look:
      Avatar
      schrieb am 26.08.08 19:58:42
      Beitrag Nr. 11 ()
      Antwort auf Beitrag Nr.: 34.854.062 von asics01 am 25.08.08 20:38:24
      ;) Nee, dafür brauche ich kein Seher sein.
      Es sind nur mächtig gewaltig viele :cry::cry::cry: in Deinen Beiträgen, wobei der Kursverlauf aber gar nicht so übel ist. Hättest Du mit :yawn::yawn::yawn: gepostet hätte ichs verstanden.
      Avatar
      schrieb am 26.08.08 20:07:02
      Beitrag Nr. 12 ()
      Antwort auf Beitrag Nr.: 34.869.441 von Biobrandschutz am 26.08.08 19:58:42da muss ich dir recht geben der kursverlauf ist nicht schlecht,könnte nicht besser sein:kiss::kiss::lick::lick::laugh::laugh:;):p:p
      Avatar
      schrieb am 29.08.08 17:15:08
      Beitrag Nr. 13 ()
      Hallo, ihr beiden,

      den Kursverlauf der Vergangenheit kann man betrachten, wie man mag. Auf Basis von sechs Jahren seitwärts oder auf Basis von fünf Jahren von links oben nach rechts unten. :rolleyes: Entscheidend sollte gerade bei einem Forschungsunternehmen die Erwartung in die zukünftige Entwicklung sein, und zwar gestützt durch das bisher geleistete.

      Herzliche Grüße
      sistra
      Avatar
      schrieb am 29.08.08 22:23:52
      Beitrag Nr. 14 ()
      die amis lieben das shorten- bei uns ist da jetzt auch mode - doch der langfristanleger gewinnt immer-
      Avatar
      schrieb am 11.09.08 10:52:38
      Beitrag Nr. 15 ()
      gestern ging vical ja mächtig in die knie,was gibt es neues???scheint aber bei vical normal zu sein dass es nur abwärts geht.
      asics
      Avatar
      schrieb am 11.09.08 14:44:59
      Beitrag Nr. 16 ()
      ein trost bleibt - laugh: bei leh gings auch mächtig runter
      Avatar
      schrieb am 12.09.08 10:15:03
      Beitrag Nr. 17 ()
      das hier ist ein sterben auf raten,ich werde meine teile raushauen und die notbremse ziehen.viel glück den investierten.:look::look::look:
      asics
      Avatar
      schrieb am 13.09.08 21:07:32
      Beitrag Nr. 18 ()
      vical wird wohl für ANGES ein millionengrab werden,ich denke ohne grund geht eine aktie nicht so den bach runter.da wissen wieder ein paar mehr als wir und ziehen ihre teile ab,jetz sind wir wieder auf dem kursniveau von 2003.die kann man wohl bald unter einem dollar kaufen.
      asics
      Avatar
      schrieb am 14.09.08 07:36:11
      Beitrag Nr. 19 ()
      kommen diese woche noch seitens vical schlechte news,und ziehen vical nochmal richtig runter:confused::confused::confused:
      Avatar
      schrieb am 16.09.08 17:22:32
      Beitrag Nr. 20 ()
      was läuft da für ein spiel ab :confused::confused::confused:
      Avatar
      schrieb am 17.09.08 10:23:41
      Beitrag Nr. 21 ()
      wäre ich doch blos am freitag raus,aber ich war nicht zuhause mir waren die hände gebunden:cry::cry::cry:
      jetzt schaue ich halt vollends zu wie vical beerdigt wird, (oder wiederaufersteht:yawn:;):)
      asics
      Avatar
      schrieb am 19.09.08 15:02:43
      Beitrag Nr. 22 ()
      für BIOBRANDSCHUTZ:yawn::yawn::kiss::kiss:;);):lick::lick::look::look:
      Avatar
      schrieb am 19.09.08 22:51:42
      Beitrag Nr. 23 ()
      siehste - rausgehen aus dem tief ist widersinnig
      Avatar
      schrieb am 30.09.08 22:29:21
      Beitrag Nr. 24 ()
      sind die bescheuert, die aus dem tie rausgehen:laugh::laugh::laugh:
      Avatar
      schrieb am 24.10.08 23:22:36
      Beitrag Nr. 25 ()
      Antwort auf Beitrag Nr.: 35.188.053 von asics01 am 19.09.08 15:02:43
      :D:kiss:
      Avatar
      schrieb am 17.11.08 18:28:36
      Beitrag Nr. 26 ()
      Hallo!

      Der Kursverlauf zeigt, dass ich zu früh eingestiegen bin. Die Gesellschaft überzeugt mich gleichwohl weiterhin.

      Gruß sistra
      Avatar
      schrieb am 17.11.08 19:11:02
      Beitrag Nr. 27 ()
      Antwort auf Beitrag Nr.: 35.980.158 von sistra am 17.11.08 18:28:36nachdem ich kurz komplett raus war,bin ich letzte woche zu 1,09€,und heute nochmal zu 0,987€ wieder rein.
      ich hätte aber nie gedacht dass vical soweit runterkommt.mal sehen obs noch weiter runter geht,oder ob der boden gefunden ist.

      asics
      Avatar
      schrieb am 17.11.08 19:31:00
      Beitrag Nr. 28 ()
      Antwort auf Beitrag Nr.: 35.980.543 von asics01 am 17.11.08 19:11:02
      Gute Entscheidung! Ich bin weiterhin zuversichtlich.
      Avatar
      schrieb am 17.11.08 21:44:27
      Beitrag Nr. 29 ()
      Antwort auf Beitrag Nr.: 35.980.697 von sistra am 17.11.08 19:31:00wenn die nicht bald was positives präsentieren,werden die wohl unter die 1$ gedrückt.
      Avatar
      schrieb am 18.11.08 18:04:27
      Beitrag Nr. 30 ()
      Antwort auf Beitrag Nr.: 35.980.697 von sistra am 17.11.08 19:31:00du kannst sagen was du willst,wenn ich mir den kursverlauf anschaue
      muß ich sagen dass da gewaltig am rad gedreht wird.nur wer und wieso:confused::confused::confused:

      asics
      Avatar
      schrieb am 19.11.08 13:26:53
      Beitrag Nr. 31 ()
      Hallo sistra,hallo Leute !

      ....bin Ex-Vical aktionär von vor 8 Jahren ("naked DNA")! Wieso habt
      ihr bei Allovectin-7 so grosse hoffnung :rolleyes::D ? Als ich
      damals "drin" war,war allovectin auch schon in Phase-3,die aber
      wegen Unwirksamkeit abgebrochen wurde.Nun hat man die dosis
      drastisch erhöht und versucht es nochmal,aber sollte man sich
      tatsächlich darauf einlassen :(? Immerhin ist Leuvectin auch schon
      eingestellt ....:(:(

      GRMPF :O!

      MFG
      Chalifmann :look:
      Avatar
      schrieb am 19.11.08 13:53:57
      Beitrag Nr. 32 ()
      Ein ganz aktuelles Posting zu vical aus dem Yahoo-Board,zum geniessen:

      "Geees losers, when are you gonna learn to never F**K with the King of Shorts!!!!!!!

      The need cash and nobody wants to give cash to perpetual, never gonna make money. never gonna have revenues, run by a bunch of idiots, invested in by bigger idiots, loser, douchebag, asswipe, technology able to be made by 8th grade science students, please use my technology...I'll let you use it for free, self promoting, never gonna get back above $2, joke of a company.

      Using all my powers to BK this company. Oh, I'm sorry, they are doing it to themselves. Burning cash at an alarming rate, with no regard for the shareholders.

      Vical, soon to feel
      In the Pinks!"

      Tja,was soll man da noch zu sagen .... :(
      Avatar
      schrieb am 14.12.08 17:23:27
      Beitrag Nr. 33 ()
      king of the assholes
      Avatar
      schrieb am 07.01.09 22:16:26
      Beitrag Nr. 34 ()
      na also 20% heute plus
      Avatar
      schrieb am 14.01.09 13:00:02
      Beitrag Nr. 35 ()
      Source: Vical Incorporated
      Vical Announces Issuance of U.S. Patent No. 7,470,675 for Composition, Delivery and Use of Gene-Based Interferon-Omega

      SAN DIEGO, Jan. 14, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today the issuance of U.S. Patent No. 7,470,675 covering the composition, delivery and use of gene-based interferon-omega. Interferon-omega is part of the interferon family of proteins which are naturally produced by the immune system. Several interferons have been approved as treatments for infectious diseases, cancer and other diseases. They typically work by directing the immune system to target foreign agents in the body and interrupt their normal growth processes.

      This patented gene-based composition was discovered and developed by Vical scientists for a broad range of potential uses. With Vical's method, a genetic sequence encoding interferon-omega is delivered into a body tissue or cavity where it enters living cells. Once inside the cells, the genetic sequence is designed to cause the cells to produce interferon-omega protein, which may help direct and control the immune system. The technologies covered by this new patent are available for licensing.

      This patent adds to Vical's family of patents in the United States and in other key regions based on the company's discovery that administering genetic sequences such as DNA or RNA into the body, without the use of viral delivery vehicles, may cause expression of the proteins encoded by the genetic sequences.

      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

      This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical's technology and its current and potential applications, the scope of coverage of and potential applications for the company's issued and future patents and the potential uses and benefits of gene-based interferon-omega, as well as the company's focus, collaborative partners, and product candidates. Risks and uncertainties include whether the company's technology will be successfully applied, whether the company's issued patents will be challenged and whether such challenges will have an adverse effect on the scope of the patents, whether the company will enforce its issued patents or will be successful in any enforcement efforts, whether the company will successfully prosecute additional patent applications and whether such applications will lead to the issuance of additional patents, whether gene-based interferon-omega, if used in human clinical trials, will be safe and effective at directing and controlling the immune system, whether the company or any of its collaborative partners will incorporate gene-based interferon-omega into any of their products, whether any product candidates will be shown to be safe and effective in clinical trials, the timing, nature and cost of clinical trials, whether Vical or its collaborative partners will seek or gain approval to market any product candidates, whether Vical or its collaborative partners will succeed in marketing any product candidates, and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

      CONTACT: Vical Incorporated
      Alan R. Engbring
      (858) 646-1127
      www.vical.com
      Avatar
      schrieb am 04.02.09 04:15:44
      Beitrag Nr. 36 ()
      4 euro hab ich für das miststück gegeben
      Avatar
      schrieb am 21.05.09 00:48:53
      Beitrag Nr. 37 ()
      :confused:
      Avatar
      schrieb am 21.05.09 18:59:20
      Beitrag Nr. 38 ()
      sieht doch gut aus... :rolleyes:


      Avatar
      schrieb am 04.06.09 23:06:11
      Beitrag Nr. 39 ()
      wie solarworld heute:laugh::laugh::laugh::laugh:
      Avatar
      schrieb am 11.06.09 21:54:00
      Beitrag Nr. 40 ()
      Antwort auf Beitrag Nr.: 37.228.341 von moneyonstreet am 21.05.09 18:59:20sieht sehr gut aus...

      resistance heute aus 1 bis 6 monats-charts rausgenommen.


      der weg ist frei für 3 dollars und more... ;)
      Avatar
      schrieb am 11.06.09 22:19:55
      Beitrag Nr. 41 ()
      Afterhours 2.79 US

      sieht sehr gut aus....

      gruß
      massel

      PS: Sinovac iss auch ordentlich angezogen....
      Avatar
      schrieb am 11.06.09 23:32:53
      Beitrag Nr. 42 ()
      Antwort auf Beitrag Nr.: 37.376.715 von Massel am 11.06.09 22:19:55After Hours: $ 2.84 0.08 (+2.90%) Volume: 16.9 k
      Avatar
      schrieb am 12.06.09 13:36:09
      Beitrag Nr. 43 ()
      :)vergiß nicht GIVN- die oldies kommen wieder
      Avatar
      schrieb am 12.06.09 22:13:18
      Beitrag Nr. 44 ()
      Vical Incorporated (VICL) said Thursday it has the necessary genetic sequence and plans to produce a prototype vaccine for the H1N1 influenza, aka Swine Flu, “within the next few days.” Wednesday, Vical announced it has entered into an agreement with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, for the expedited development of a Swine Flu vaccine. The goal is to get the vaccine into clinical testing as quickly as possible.

      http://seekingalpha.com/article/142928-healthcare-stocks-fav…
      Avatar
      schrieb am 12.06.09 22:16:37
      Beitrag Nr. 45 ()
      VICL: Thomas Weisel Starts @ Overweight; Sets Tgt @ $5; Analyst Notes

      Friday , June 12, 2009 08:39ET

      Issuer: Vical, Incorporated (NasdaqNM: VICL)

      Analyst Firm: Thomas Weisel Partners

      Ratings Action: INITIATE

      Current Rating: Overweight

      Target Price Action: INITIATE
      Target Price: $5.00

      Analyst Comments: Thomas Weisel initiated Vical with an Overweight rating. The firm believes the company has a diverse clinical pipeline and represents an attractive risk/reward opportunity.
      Avatar
      schrieb am 12.06.09 22:20:22
      Beitrag Nr. 46 ()
      shorter sind schon wieder am werk!

      Avatar
      schrieb am 12.06.09 22:38:15
      Beitrag Nr. 47 ()
      den amis kannst du nicht trauen - ich verstehe sehr gut, dass temasek aus den amiaktien raus ist
      Avatar
      schrieb am 12.06.09 22:50:55
      Beitrag Nr. 48 ()
      meine 4 euro werde ich wohl nie wiedersehen
      Avatar
      schrieb am 12.06.09 23:13:41
      Beitrag Nr. 49 ()
      Antwort auf Beitrag Nr.: 37.385.545 von Kurumba am 12.06.09 22:50:55Kopf hoch, ich bin auch stinksauer :mad:, hatte mir für heute vielmehr versprochen.......

      Da rufen die schon die Stufe 6 aus, erstmalig nach 40 Jahren und
      was machen die meisten relevanten Werte:

      Dümpeln heute in der Gegend rum :mad::mad:

      Nichts desto Trotz:


      1 gute News und Du siehst mehr als 4 Euro , NUR SIE MUSS KOMMEN....
      Avatar
      schrieb am 17.06.09 16:11:19
      Beitrag Nr. 50 ()
      thx for the cheapies 2.000 @ 1.79 ffm ;)
      Avatar
      schrieb am 18.06.09 14:20:19
      Beitrag Nr. 51 ()
      NEWS:


      Vical Advances RapidResponse(tm) DNA Vaccine Platform Under $6 Million Grant From NIH


      SAN DIEGO, June 18, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced that the company has successfully completed second-year milestones under a three-year, $6.0 million grant awarded in 2007, and is advancing with the development of a DNA vaccine manufacturing process with the potential to produce several million doses of vaccines in a matter of days.

      The RapidResponse(tm) system is designed to allow extremely rapid and large-scale production of DNA vaccines with low capital requirements. It is ideally suited to enable an immediate response against emerging diseases affecting large populations, such as H1N1 or H5N1 pandemic influenza or severe acute respiratory syndrome (SARS). The company is proceeding with the development of the RapidResponse(tm) platform under the third year of grant funding awarded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

      About the RapidResponse(tm) Platform

      The RapidResponse(tm) DNA vaccine manufacturing platform is intended to significantly reduce the time required to develop, manufacture and deploy vaccines against emerging diseases during the early stages of an infectious outbreak. By using a cell-free manufacturing process, the company believes that the RapidResponse(tm) DNA platform can overcome the time, capacity and cost challenges of manufacturing conventional vaccines for diseases such as influenza, which use viruses grown in chicken eggs or via cell culture, requiring months of production time in large, dedicated facilities.

      RapidResponse(tm) DNA vaccine manufacturing involves a cell-free process and single-step vaccine purification. The process has the potential to be scaled up by simply using larger equipment with no increase in production time, conceivably allowing production of hundreds of millions of doses of DNA vaccine during the earliest stages of an outbreak. Such speed and scale may be crucial in addressing a naturally emerging potentially pandemic disease such as influenza or SARS, an accidental release of a dangerous pathogen such as Ebola virus or Yersinia pestis (plague bacterium) from a biological containment facility, or an intentional release of a weaponized or bioterrorist-modified pathogen designed to cause diseases such as anthrax or smallpox.

      Initial research testing demonstrated 100% protection of mice against a lethal challenge with an H3N2 influenza virus after a single 2 microgram dose of Vaxfectin(r)-formulated DNA vaccine produced by polymerase chain reaction (PCR). The goals in the final year of grant funding are to complete scale-up of vaccine production and complete animal safety testing.

      The PCR process produces a segment of DNA, called a linear expression cassette (LEC), which includes only those DNA sequences essential for eliciting immune responses. The bacterial fermentation process typically used for DNA vaccines produces a closed loop of DNA, called a plasmid, which includes DNA sequences required by the bacteria in the manufacturing process. Vical holds patents in the United States and in other key regions based on the company's discovery that administering polynucleotides such as DNA or RNA to tissues, without the use of viral delivery vehicles, may cause expression of the proteins encoded by the polynucleotides. Vical's patent coverage includes delivery of linear DNA as well as plasmid DNA.

      Currently plasmid DNA vaccines, which are under development against pandemic influenza and other infectious diseases at Vical, are manufactured by bacterial fermentation in standardized equipment with a production time measured in weeks rather than months. While plasmid DNA vaccines offer a significant improvement over conventional vaccine manufacturing technologies, the RapidResponse(tm) DNA vaccine platform could offer further advantages, especially in greater speed of production and lower cost. The company plans to continue development of its plasmid DNA vaccine programs because the technology is much closer to commercial realization in humans.

      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

      This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether Vical or others will continue development of the RapidResponse(tm) DNA vaccine platform; whether the company will receive all, if any, of the NIH grant funding; whether the RapidResponse(tm) platform will reduce the time required to develop, manufacture and deploy vaccines against emerging diseases during the early stages of an infectious outbreak and overcome the time, capacity and cost challenges of manufacturing conventional vaccines; whether RapidResponse(tm) platform will successfully be scaled up to allow the production of hundreds of millions of doses of DNA vaccines during the earliest stages of an outbreak; whether the RapidResponse(tm) platform will be applicable to a broad range of emerging diseases; whether Vical will complete scale-up of vaccine production and complete animal safety testing in the final year of grant funding, if at all; whether the company's DNA vaccine candidates will be effective against emerging pathogens; whether the influenza vaccine or any other product candidates will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market the influenza vaccine or any other product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; whether the company's issued patents will be challenged and whether such challenges will have an adverse effect on the scope of the patents; whether the company will enforce its issued patents or will be successful in any enforcement efforts; whether the company will be issued additional patents on the RapidResponse(tm) process or applications; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

      CONTACT: Vical IncorporatedAlan R. Engbring
      (858) 646-1127
      www.vical.com





      Latest "In Focus" News Stories

      * Credit card companies more willing to negotiate

      Jun 17, 2009
      * Consumers can expect tighter credit conditions

      Jun 16, 2009
      * Auto loan delinquencies fell somewhat last quarter

      Jun 15, 2009
      * Travel and tourism appear to be riding out recession

      Jun 12, 2009
      * World economy seen as shrinking 3 percent

      Jun 12, 2009




      -------------------------------------------------------------

      Pre-Market
      Last: $ 2.79 Pre-Market
      High: $ 2.95
      Pre-Market
      Volume: 12,300 Pre-Market
      Low: $ 2.66
      Pre-Market
      Time (ET) Pre-Market
      Price Pre-Market
      Share Volume
      08:12 $ 2.79 200
      08:12 $ 2.80 200
      08:12 $ 2.80 500
      08:12 $ 2.80 300
      08:12 $ 2.95 400
      08:11 $ 2.75 1,000

      ---------------------------------------------

      gruß
      massel
      Avatar
      schrieb am 18.06.09 14:22:28
      Beitrag Nr. 52 ()
      Pre-Market
      Last: $ 2.85 Pre-Market
      High: $ 2.95
      Pre-Market
      Volume: 21,700 Pre-Market
      Low: $ 2.66
      Pre-Market
      Time (ET) Pre-Market
      Price Pre-Market
      Share Volume
      08:16 $ 2.85 2,500
      Avatar
      schrieb am 18.06.09 23:30:15
      Beitrag Nr. 53 ()
      Ein Satz mit "X" :

      Das war dann doch niX !
      Avatar
      schrieb am 19.06.09 14:10:15
      Beitrag Nr. 54 ()
      heute - glaub ich, ist es soweit- bin gespannt
      Avatar
      schrieb am 19.06.09 22:33:25
      Beitrag Nr. 55 ()
      für 2.39 kauft jemand 10 0000 stücke - ob das hilft?
      Avatar
      schrieb am 19.06.09 23:02:09
      Beitrag Nr. 56 ()
      Antwort auf Beitrag Nr.: 37.431.526 von Kurumba am 19.06.09 22:33:25das ist doch alles dermassen gesteuert und unverhersehrbar was momentan passiert/manipuliert wird, da kann man genauso ins Kasino gehen...(kurzfristig gesehen)

      Das Einzige was diese Herschaften aber nicht dirigieren können
      ist die Entwicklung der Schweinegrippe.
      Also langfristig wird sich der Trend unterm Strich nicht mehr verhindern lassen können.

      Schau Dir mal z.B. die heutigen Verlauf von Sinovac an.
      Da wurde auf einmal draufgeprügelt, bloß das die Aktie schön unten bleibt und die Anleger verunsichert werden....

      gruß
      massel
      Avatar
      schrieb am 26.06.09 22:38:22
      Beitrag Nr. 57 ()
      mein gott -wie bekloppt sind die amis eigendlich - ich wiederhole - den staatafond von singapur kann ich gut verstehen - amis sind nur short- weil sie kein geld mehr haben- kackamis- ekelvolk -nicht mal respekt vor dem erfolg ihrer eigenen firmen - die sind soooooowas an doooooooof - -kennen nur apple . goog, rimmm . amzn - dummmes volk - das musste ich mal loswerden - sorry
      Avatar
      schrieb am 26.06.09 22:40:07
      Beitrag Nr. 58 ()
      kann ich verstehen , hast RECHT !!

      gruß
      massel
      Avatar
      schrieb am 26.06.09 23:05:49
      Beitrag Nr. 59 ()
      auf bessere zeiten und den nachhaltigen durchbruch ;)


      RAiDAR alerts Learn More About RAiDAR-LT


      06/26/2009 (16:23 ET) VICL: Jumps +4.80%; Vol +850%; Last 90 Min of Trading - Knobias



      06/26/2009 (16:16 ET) VICL: Volume Spike; 295% > 20-adsv, Stock +3.90% - Knobias
      Avatar
      schrieb am 27.06.09 01:34:41
      Beitrag Nr. 60 ()
      wer ist eigendlich dieser idiot macrokosmomaut- spukt überall herum - bashed- pushed - also -boerse ist doch hrank, solange solche idioten drin sind
      Avatar
      schrieb am 27.06.09 13:19:20
      Beitrag Nr. 61 ()
      VICL ist dabei!! :cool:

      June 26 Updates to the list of additions and deletions
      Reconstitution final after the close of the U.S. markets


      http://www.russell.com/indexes/membership/reconstitution/Rec…
      Avatar
      schrieb am 30.06.09 16:13:24
      Beitrag Nr. 62 ()
      schöner sprung heute - wetten, dass in kürze alles wieder weg ist ...:D
      Avatar
      schrieb am 30.06.09 18:57:05
      Beitrag Nr. 63 ()
      Antwort auf Beitrag Nr.: 37.494.056 von Kurumba am 30.06.09 16:13:24meistens kommte es anders als man dankt :confused: gerade wenn das trading pattern zuletzt so aussah ;)


      irgendwann sind sie alle genervt dass VICL auf der stelle tritt und dann schleicht sie auf und davon :D


      06/30/2009 (12:09 ET) Emerging Markets Consulting, LLC.: Emerging Markets Consulting, LLC. : Emerging Equity Alerts - M2 Communications



      06/30/2009 (11:45 ET) Vical (VICL) NewsBite - VICL Could Be On The Move - Fresh Brewed Media



      06/30/2009 (11:24 ET) StandoutStocks.com: "Stocks that Standout" picks for today are: CGEN, ERTS, IARO, VICL - M2 Communications



      06/30/2009 (11:02 ET) LiquidTycoon.com: is the Highest PercentageGeron Corporation (NASDAQ:GERN) Gainers Among NASDAQ Stocks During Morning Trading Hours - M2 Communications



      06/30/2009 (10:26 ET) Markets Move Sharply Lower After Consumer Confidence Data - Knobias



      06/30/2009 (10:10 ET) VICL: Volume Spike; 26% > 20-adsv, Stock +27.27% - Knobias



      06/30/2009 (09:31 ET) Wall Street News Alert: Trade Alert: VICL, GERN - M2 Communications



      06/30/2009 (08:42 ET) VICL: Positive Results in Study of Pandemic Swine Flu Vaccine - Knobias



      06/30/2009 (06:30 ET) Vical H1 Influenza Vaccine Delivers Robust Preclinical Results With 100% Response - GlobeNewswire
      Avatar
      schrieb am 30.06.09 18:58:14
      Beitrag Nr. 64 ()
      Vical (VICL) NewsBite - VICL Could Be On The Move

      Tuesday , June 30, 2009 11:45ET

      Jun 30, 2009 (Fresh Brewed Media via COMTEX) -- Vical (VICL) was covered in a Bloomberg Video Report today and the stock is now at $2.61, up $0.41 (18.64%) on volume of 4,927,858 shares traded. To see the video report go to http://www.marketintelligencecenter.com/VideoNews . Over the last 52 weeks the stock has ranged from a low of $1.04 to a high of $4.09. Vical stock has been showing support around $2.09 and resistance in the $2.41 range. Technical indicators for the stock are neutral and S&P gives VICL a neutral 3 STARS (out of 5) hold ranking. We will just watch this one for now. There are no hedged trades we like the look of for VICL.

      ABR-Seven Summits Strategic Investments NewsBite Goto www.iotogo.com/18w1 for our free report titled, The 18 Ways To Know When It's Time To Dump A Stock

      (C) Copyright 2009, Fresh Brewed Media. All rights reserved.
      Avatar
      schrieb am 30.06.09 21:12:45
      Beitrag Nr. 65 ()
      Antwort auf Beitrag Nr.: 37.495.559 von moneyonstreet am 30.06.09 18:57:05gibt noch mehr davon...:lick:


      06/30/2009 (13:24 ET) Markets Remain Near Lows After Disappointing Consumer Confidence Data - Knobias



      06/30/2009 (13:14 ET) xtremepicks.com: www.Xtremepicks.com: www.Xtremepicks.Com: Xtremepicks.Com Alerts For Tuesday, June 30, 2009: GERN, VICL, XNPT, CGEN, And HX - M2 Communications



      06/30/2009 (12:47 ET) PicksThatMove: www.PicksThatMove.com: www.PicksThatMove.com: www.PicksThatMove.com Alerts, June 30, 2009: IDTI, TASR, GERN, FFIV, VIRL and VICL. - M2 Communications
      Avatar
      schrieb am 30.06.09 21:13:58
      Beitrag Nr. 66 ()
      Markets Remain Near Lows After Disappointing Consumer Confidence Data

      Tuesday , June 30, 2009 13:24ET

      The major indices have been able to move off the lows of the day, but the markets are still showing sharp loss. The decline in stocks began just after this morning’s consumer confidence data which showed a decline from the previous month reading of 54.9 to this month’s reading of 49.3 which was well below the reading of 56 that was expected. This is considered a bearish indicator for stocks and is especially troublesome if coming after a previous reading above 50. While the market continues to bounce back and forth, some believe this could be a good thing as stocks begin to consolidate after moving virtually sideways since May. As June ends and traders usher in July, economic data will be on everyone’s mind ahead of the extended holiday weekend. The next two days will bring the latest ADP Employment data and also the government’s report on employment. This should keep investors interested in the market and keep volume at a decent level on a typically low volume week. Corporate headlines from this morning include the order for Abbot to pay J&J $1.67 billion in a patent litigation case, and earnings results from both H&R Block and Apollo Group. Oil prices have also tumbled under the selling pressure in equities and have moved back below the $70 mark while gold prices have also continued to slide and are now back below $930.

      TOP STORIES :eek:
      - Abbott Ordered to Pay J&J $1.67b in Humira Patent Case
      - Broadcom Raises All-Cash Tender Offer for Emulex to $11.00 Per Share
      - UK GDP Slumped to a Downwardly Revised 2.4% in Q1
      - BG Group to Buy Stake in Exco Resources' Shale Gas Project for $1.06b
      - The Bank of New York Mellon Makes Strategic Investment in International Derivatives Clearing Group
      - H&R Block Reports Q4 Adj EPS $2.09 vs $2.09 Beats $2.05 Est; Guidance In-Line with Consensus
      - Ford Official Says June Could be US Auto Industry's Best Month Since Last Fall
      - Apollo Group Reports Q3 EPS $1.26 vs 85c Beats $1.12 Est
      - XenoPort Reports Positive Results from a Phase 2 Trial of Arbaclofen Placarbil in Spinal Cord Injury Patients with Spasticity
      - GE Healthcare and Geron Announce Exclusive Global Agreement to Commercialize Stem Cell Drug Discovery Technologies
      - Vical H1 Influenza Vaccine Delivers Robust Preclinical Results With 100% Response :cool:

      ECONOMIC DATA
      - 07:45 - Chain Store Sales for w/e June 27 (actual: +1.6%; previous: 0.0%)
      - 08:55 - Redbook Index for w/e June 27 (actual: -4.4%; previous: -4.4%)
      - 09:00 - Case-Shiller Home Price Index for April, 10-City Index (actual: --; previous: -18.6%)
      - 09:00 - Case-Shiller Home Price Index for April, 20-City Index (actual: --; expected: -18.6% previous: -18.7%)
      - 09:45 - Chicago PMI for June (actual: 39.9; expected: 39; previous: 34.9)
      - 09:45 - DJ Economic Sentiment Index for June (actual: 31.8; previous: 29)
      - 10:00 - Conference Board Consumer Confidence Index for June (actual: 49.3; expected: 56; previous: 54.9)

      US MARKET
      - Nasdaq (1827.57, -16.49, -0.89%)
      - Dow (8412.99, -116.39, -1.36%)
      - S&P 500 (915.26, -11.97, -1.29%)

      FOREIGN MARKET RECAP
      Asia
      - Nikkei 225: (9,958.44, +174.97, +1.73%)
      - Shanghai Comp: (2,959.36, -15.95, -0.54%)
      - Hang Seng: (18,378.73, -149.78, -0.81%)
      - Dollar/Yen: (1 Dollar = ¥96.31)

      Europe
      - DAX: (4,808.64, -76.45, -1.56%)
      - FTSE 100: (4,249.21, -44.82, -1.04%)
      - CAC 40: (3,140.44, -53.24, -1.67%)
      - IBEX 35: (9,787.80, -57.90, -0.59%)
      - Euro/Dollar: (1 Euro = $1.40)

      COMMODITIES/BONDS
      - Crude (69.59, -1.90, -2.66%)
      - Gold (929.7, -11.00, -1.17%)
      - 5-Year Treasury Note (2.54%, +0.05)
      - 10-Year Treasury Note (3.50%, +0.01)
      Avatar
      schrieb am 01.07.09 22:10:50
      Beitrag Nr. 67 ()
      aller guten dinge sind drei... :rolleyes:


      Avatar
      schrieb am 01.07.09 22:47:34
      Beitrag Nr. 68 ()
      :D
      Avatar
      schrieb am 23.07.09 23:23:55
      Beitrag Nr. 69 ()
      Antwort auf Beitrag Nr.: 37.504.016 von Kurumba am 01.07.09 22:47:34mit ein bisserl geduld sind das bislang 40 - 50 % binnert 4 - 6 wochen!!


      wohl zu langer zeitraum für einige und aktie optisch zu teuer weil über 1 euro :D


      so ist das halt und wie lautet der threadtitel: Anleger ohne langen Atem - VICAL - ;)
      Avatar
      schrieb am 23.07.09 23:26:21
      Beitrag Nr. 70 ()
      Antwort auf Beitrag Nr.: 37.385.364 von moneyonstreet am 12.06.09 22:16:37späteres update für target dollar fünf nicht ausgeschlossen!! :rolleyes:

      #45 von moneyonstreet Benutzerinfo Nachricht an Benutzer Beiträge des Benutzers ausblenden 12.06.09 22:16:37 Beitrag Nr.: 37.385.364
      Dieses Posting: versenden | melden Diskussion drucken

      VICL: Thomas Weisel Starts @ Overweight; Sets Tgt @ $5; Analyst Notes

      Friday , June 12, 2009 08:39ET

      Issuer: Vical, Incorporated (NasdaqNM: VICL)

      Analyst Firm: Thomas Weisel Partners

      Ratings Action: INITIATE

      Current Rating: Overweight

      Target Price Action: INITIATE
      Target Price: $5.00

      Analyst Comments: Thomas Weisel initiated Vical with an Overweight rating. The firm believes the company has a diverse clinical pipeline and represents an attractive risk/reward opportunity.
      Avatar
      schrieb am 23.07.09 23:32:11
      Beitrag Nr. 71 ()
      gibt auch noch andere shares mit nachholbedarf... :look:

      Avatar
      schrieb am 23.07.09 23:56:30
      Beitrag Nr. 72 ()
      peanuts trades but 3 dollars are in :cool:


      Depth/Level II for Vical Inc. (VICL)
      $ 2.87 0.02 (+0.70%) Volume: 881.15 k 16:00 EDT 23.07.2009
      After Hours: $ 3.05 0.18 (+6.27%) Volume: 4.76 k 16:52 EDT 23.07.2009
      Avatar
      schrieb am 24.07.09 18:46:25
      Beitrag Nr. 73 ()
      VICL geht zurück auf los... derzeit 3,2 dollaros :cool:
      Avatar
      schrieb am 24.07.09 19:11:52
      Beitrag Nr. 74 ()
      Will H1N1 Vaccines be Approved Before Safety Tests are Complete? :eek:

      http://finance.yahoo.com/news/Will-H1N1-Vaccines-be-indie-41…
      Avatar
      schrieb am 24.07.09 21:40:27
      Beitrag Nr. 75 ()
      guck mal wie die angsthasen wieder rauslaufen - ich stehe auf GIVN
      Avatar
      schrieb am 24.07.09 22:13:14
      Beitrag Nr. 76 ()
      Antwort auf Beitrag Nr.: 37.644.127 von Kurumba am 24.07.09 21:40:27sind schon wieder zurück die käufer, SK 3.19 dollar.

      Open
      2.94

      High
      3.29

      Low
      2.90

      Prev Close
      2.87
      Avatar
      schrieb am 24.07.09 22:36:42
      Beitrag Nr. 77 ()
      - meine nächsten sind PMTI und GIVn - hatte heute auch gute gewinne mit ALGN 21% im plus
      Avatar
      schrieb am 27.07.09 19:48:34
      Beitrag Nr. 78 ()
      Antwort auf Beitrag Nr.: 37.636.867 von moneyonstreet am 23.07.09 23:32:11so bin heute raus aus VICL und setze auf den "nachzügler", siehe oben :look:
      Avatar
      schrieb am 27.07.09 20:27:24
      Beitrag Nr. 79 ()
      hier mal eine schöne performance bzgl. bio-werte. viele sind schon gut gelaufen, auch VICL trau ich mehr zu, ist derzeit aber in RSI hotzone und wird m.E. zurück kommen. möchte gerne nochmal billiger rein!

      ich setzte jetzt auf den/die nachzügler. wenn die alle bis DNDN-niveau rennen... :rolleyes:

      Avatar
      schrieb am 27.07.09 20:36:13
      Beitrag Nr. 80 ()
      für die VICL-chartfreunde, rsi in hotzone!


      http://investorshub.advfn.com/boards/read_msg.aspx?message_i…
      Avatar
      schrieb am 27.07.09 21:30:10
      Beitrag Nr. 81 ()
      TH 3.96 dollars.. aktuell 3.60 dollars... mal schauen siehe unten!


      Vical (VICL) Bullish Technical Alert - Trend Up 61.9%

      Monday , July 27, 2009 10:09ET

      Jul 27, 2009 (SmarTrend(R) Spotlight via COMTEX) -- Vical (NASDAQ:VICL) is trading 10.7% higher (up $0.34 to $3.53) today on volume of 950,307 shares. The stock is trading near its 52-week high of $3.73. We are watching for a close above that level. :rolleyes:

      Vical is currently above its 50-day moving average of $2.44 and above its 200-day moving average of $1.92.

      SmarTrend is bullish on shares of VICL and our subscribers received an Uptrend alert on April 02, 2009 at $2.18, which has returned 61.9% to date.

      Write to Chip Brian at cbrian@tradethetrend.com

      ---------------------------------------------------------------------------------------------

      SmarTrend analyzes over 5,000 securities simultaneously throughout the trading day and provides its subscribers with trend change alerts in real time. To get a free trial of our trading calls and maximize your trading results, please visit http://www.TradeTheTrend.com.

      Get exclusive, actionable insight into how the market is expected to trend prior to market open with our free morning newsletter. Sign up at: http://www.TradeTheTrend.com/signup.html

      Copyright, Comtex News Network, Inc. 2009

      **********************************************************************

      As of Thursday, 07-23-2009 23:59, the latest Comtex SmarTrend® Alert,
      an automated pattern recognition system, indicated a DOWNTREND on
      08-04-2008 for VICL @ $3.30.

      For more information on SmarTrend, contact your market data
      provider or go to www.mysmartrend.com

      SmarTrend is a registered trademark of Comtex News Network, Inc.
      Copyright © 2004-2009 Comtex News Network, Inc. All rights reserved.
      Avatar
      schrieb am 28.07.09 12:42:03
      Beitrag Nr. 82 ()
      Federated Kaufmann Funds to Invest $10 Million in Vical

      Tuesday , July 28, 2009 06:30ET


      SAN DIEGO, July 28, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced that it has received a commitment from the Federated Kaufmann Funds to purchase $10.0 million of its common stock in a registered direct offering. Vical will sell approximately 2.8 million shares at a price of $3.63 per share, the Nasdaq closing consolidated bid price on July 27, 2009, with no warrants or commissions. The closing of the offering is expected to take place on July 30, 2009. Proceeds from the transaction will be used in the further development of Vical's ongoing programs, as well as for other general corporate purposes.

      A shelf registration statement relating to the shares of common stock to be issued in the offering has been filed with the Securities and Exchange Commission (the "SEC") and has been declared effective. A prospectus supplement relating to the offering will be filed with the SEC. Copies of the prospectus supplement and accompanying prospectus may be obtained directly from the Company by contacting Vical Incorporated, 10390 Pacific Center Court, San Diego, California 92121. This announcement is neither an offer to sell nor a solicitation of an offer to buy any of shares of Vical's common stock. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

      This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether the Federated Kaufmann Fund will fulfill its obligation to purchase the securities, whether Vical will be able to satisfy its conditions to close the offering, whether Vical will be able to continue to raise additional capital as needed to fund its operations; whether any product candidates will be shown to be safe and efficacious in clinical trials; the timing of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; the dependence of the company on its collaborative partners; and additional risks set forth in the company's filings with the SEC. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

      --------------------------------------------------------------------------------
      CONTACT: Vical Incorporated
      Alan R. Engbring
      (858) 646-1127
      www.vical.com
      Avatar
      schrieb am 28.07.09 15:56:44
      Beitrag Nr. 83 ()
      Antwort auf Beitrag Nr.: 37.659.493 von moneyonstreet am 28.07.09 12:42:03
      Avatar
      schrieb am 28.07.09 22:44:42
      Beitrag Nr. 84 ()
      Antwort auf Beitrag Nr.: 37.636.867 von moneyonstreet am 23.07.09 23:32:11#71 von moneyonstreet Benutzerinfo Nachricht an Benutzer Beiträge des Benutzers ausblenden 23.07.09 23:32:11 Beitrag Nr.: 37.636.867
      Dieses Posting: versenden | melden Diskussion drucken

      gibt auch noch andere shares mit nachholbedarf... schau mal




      chart XOMA


      Avatar
      schrieb am 28.07.09 23:03:33
      Beitrag Nr. 85 ()
      chart VICL





      chart XOMA


      Avatar
      schrieb am 29.07.09 15:25:28
      Beitrag Nr. 86 ()
      inovio bricht aus
      Avatar
      schrieb am 29.07.09 22:09:35
      Beitrag Nr. 87 ()
      und GIVN - aber auch PMTI - schade, dass ich nichts mehr investiere - gucke halt nur zu - bei den aktien, die ich im depot habe
      Avatar
      schrieb am 31.08.09 18:46:04
      Beitrag Nr. 88 ()
      Antwort auf Beitrag Nr.: 37.661.494 von vanillamilkshake am 28.07.09 15:56:44
      :D Kursanstieg in Frankfurt auf 3,35 EUR. Inzwischen merken auch hierzulande die ersten, dass bei Vical mächtig was im Busch ist.

      Gruß Bio
      Avatar
      schrieb am 06.09.09 00:22:48
      Beitrag Nr. 89 ()
      :rolleyes: Wen es interessiert:

      Nachdem es bei VICL seit Threaderöffnung recht gut gelaufen ist, habe ich bei ARRY einen neuen Thread: (The Next Blockbuster Drug) Noch nicht kaufen: ARRAY BIOPHARMA aufgemacht, bin dort aber noch nicht investiert.

      Gruß sistra
      Avatar
      schrieb am 30.09.09 15:34:42
      Beitrag Nr. 90 ()
      Source: Vical Incorporated
      Vical Licensee Sanofi-aventis Completes Enrollment in Phase 3 Angiogenesis Trial
      SAN DIEGO, Sept. 28, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company's licensee, sanofi-aventis, has confirmed the completion of enrollment in a multinational 500-patient pivotal Phase 3 clinical trial of its angiogenesis therapy based on Vical's non-viral DNA delivery technology. Sanofi-aventis expects final data from this trial in late 2010.

      "We are pleased that sanofi-aventis, one of our two partners in the angiogenesis field, has advanced according to plan with the Phase 3 testing of this novel therapy," said Vijay B. Samant, Vical's President and Chief Executive Officer, "and we would expect timely trial completion. Angiogenesis is among the most promising near-term human applications of our DNA delivery technology, and represents a substantial potential market for which there is no adequate therapy. The ability of plasmid DNA to induce production of angiogenesis protein locally at the site of injection ideally matches the desired treatment profile for peripheral vascular disease."

      The NV1FGF therapy contains DNA encoding Fibroblast Growth Factor 1 (FGF-1), a growth factor that stimulates the growth of blood vessels, and is intended to reduce the need for amputations in patients suffering from critical limb ischemia. Sanofi-aventis previously reported results from a Phase 2 trial in 107 patients demonstrating a statistically significant reduction in the rate of both major amputations and all amputations in patients receiving NV1FGF compared with those receiving placebo.

      The TAMARIS study is a double-blind, placebo-controlled Phase 3 trial in approximately 500 patients with critical limb ischemia. Four doses of 4 mg each are administered by intramuscular injection at two-week intervals, and follow-up continues for one year. The primary objective of the study is to demonstrate the superiority of NV1FGF treatment over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia patients with skin lesions. Additional information on the trial is available at www.clinicaltrials.gov/ct2/show/NCT00566657.


      Die Aktie konsolidiert derzeit bei 4,30 /4,40 USD knapp über der aufsteigenden 38-Tage-Linie. Ich denke, der Wert könnte in den nächsten Tagen seine Aufwärtsbewegung fortsetzen.
      Avatar
      schrieb am 30.09.09 22:43:41
      Beitrag Nr. 91 ()
      oh ja , schön wärs
      Avatar
      schrieb am 01.10.09 13:43:27
      Beitrag Nr. 92 ()
      Antwort auf Beitrag Nr.: 38.090.806 von Kurumba am 30.09.09 22:43:41Alles deutet darauf hin, dass VICAL weiter steigt.
      Heute in der Vorbörse 10/1/2009 7:41:33 AM Kurs 4,58 USD, das sind 7,51% Plus gegenüber Vortagesschluss.
      Grund der Steigerung noch nicht erkennbar. Meldung kommt vielleicht noch.
      Avatar
      schrieb am 01.10.09 13:47:39
      Beitrag Nr. 93 ()
      U.S. Navy to Fund Vical's H1N1 Pandemic Influenza (Swine Flu) Vaccine



      SAN DIEGO, Oct. 1, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the U.S. Navy has awarded a contract for $1.25 million to support large-scale cGMP vaccine manufacturing and related clinical and regulatory preparations, which are already underway, for a Phase 1 clinical trial of the company's vaccine against A/H1N1 pandemic influenza (swine flu). The trial will be conducted in collaboration with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the Navy.

      "The current threat from H1N1 influenza and the potential for other future pandemics from strains like H5N1 call for a proactive approach to developing new vaccine technologies, such as DNA vaccines, that can be deployed rapidly," said Vijay B. Samant, Vical's President and Chief Executive Officer. "We are pleased with the Navy's vision in funding this important vaccine development program, which can benefit from their experience and capability to advance this program to the next stage."

      As previously announced, Vical was the first company to produce a vaccine against the A/H1N1 influenza virus after the initial reports of widespread outbreaks in Mexico, and the first to announce robust immunogenicity results from animal testing in two species. Within days of the outbreaks, the company entered into a Cooperative Research and Development Agreement (CRADA) with NMRC to conduct clinical testing of an H1 DNA vaccine formulated with Vical's patented Vaxfectin(R) adjuvant.
      Avatar
      schrieb am 01.10.09 14:07:14
      Beitrag Nr. 94 ()
      Die Förderung durch die Navy deutet darauf hin, dass VICAL bei der H1N1 pandemic influenza (swine flu)-Foschung in den USA eindeutig die Nase vorn hat.
      Weiter steigende Kurse in der Vorbörse: jetzt über 9% Plus!
      Avatar
      schrieb am 01.10.09 23:13:25
      Beitrag Nr. 95 ()
      Antwort auf Beitrag Nr.: 38.094.648 von aktionaer-froehlich am 01.10.09 14:07:14... und dann haben die AMIs wieder alles weggeschossen, so dass am Ende des Tages sogar noch ein MINUS von 5,87% gegenüber dem Vortag einzuordnen ist!!!
      Damit ist aber leider auch, und das trotz der guten Nachricht, die 38-Tage-Linie nach unten durchbrochen. :(
      Avatar
      schrieb am 27.10.09 22:17:07
      Beitrag Nr. 96 ()
      ach nee - aus tiefstem keller..
      Avatar
      schrieb am 27.10.09 22:24:24
      Beitrag Nr. 97 ()
      Antwort auf Beitrag Nr.: 38.265.773 von Kurumba am 27.10.09 22:17:07
      :confused: Wieso, läuft doch!
      Avatar
      schrieb am 28.10.09 22:58:27
      Beitrag Nr. 98 ()
      ich seh nix
      Avatar
      schrieb am 18.12.09 01:19:01
      Beitrag Nr. 99 ()
      betrügerbande
      Avatar
      schrieb am 28.12.09 19:00:48
      Beitrag Nr. 100 ()
      :eek:

      Vical hat mit Allovectin offenbar den Schlüsselwirkstoff gegen Hautkrebs in der Pipeline. Nach den heutigen Meldungen darüber geht es um mehr als 30% rauf.
      Avatar
      schrieb am 30.12.09 22:57:39
      Beitrag Nr. 101 ()
      läuft wieder - wenn auch mühsam
      Avatar
      schrieb am 11.02.10 14:52:19
      Beitrag Nr. 102 ()
      Zahlen sind da auf Homepage : www.vical.com

      :cool::cool:
      Gruß der Charmante
      Avatar
      schrieb am 03.08.10 11:30:37
      Beitrag Nr. 103 ()
      Ist hier noch jemand? ich habe gerade über VICAL im Aktionär gelesen, ich investiere seit längerem ausnahmslos in Biotechwerte und trage mich mit dem Gedanken einzu steigen!?
      Avatar
      schrieb am 03.08.10 14:49:35
      Beitrag Nr. 104 ()
      läuft jetzt wieder- schweinegrippe ist ausgerufen
      Avatar
      schrieb am 04.08.10 10:19:00
      Beitrag Nr. 105 ()
      Antwort auf Beitrag Nr.: 39.919.650 von Kurumba am 03.08.10 14:49:35http://www.welt.de/die-welt/regionales/article8807504/Impfst…
      Avatar
      schrieb am 06.08.10 13:09:26
      Beitrag Nr. 106 ()
      Hallo !

      Überlege auch hier einzusteigen.

      Wäre dankbar über kurz zusammengefaßte Infos, da ich nur Infos von der HP habe.

      Welche Erfahrungen haven shareholders mit dieser Akitie in der Vergangenheit gemacht usw.
      4 Antworten
      Avatar
      schrieb am 06.08.10 23:10:21
      Beitrag Nr. 107 ()
      gute
      Avatar
      schrieb am 07.08.10 09:05:23
      Beitrag Nr. 108 ()
      Antwort auf Beitrag Nr.: 39.941.343 von 1bull007 am 06.08.10 13:09:26Die Jungs hier sind nicht so gesprächig, liegt wahrscheinlich daran, dass z.Z. auch nicht viel zu sagen ist. Kursrelevante Daten kommen laut dem Artikel aus den aktuellen "Aktionär" erst Mitte nächsten Jahres. Durch den bin ich aufmerksam geworden, vielleicht hast du`s ja auch gelesen?
      Meine Meinung ist, das man mit etwas Glück bis dahin auch noch günstiger rein kommt.
      Mein Focus liegt so bei 2,2-2,3 €.
      Hier ein link wo du nch ein paar Zahlen findest:
      http://finance.yahoo.com/q?s=VICL
      Gruss ts :cool:
      4 Antworten
      Avatar
      schrieb am 10.08.10 20:04:19
      Beitrag Nr. 109 ()
      Antwort auf Beitrag Nr.: 39.946.067 von LeBarbier am 07.08.10 09:05:23lesezeichen
      Avatar
      schrieb am 11.08.10 09:33:50
      Beitrag Nr. 110 ()
      Antwort auf Beitrag Nr.: 39.961.240 von Ahorne am 10.08.10 20:04:19lesezeichen...
      :confused:
      Avatar
      schrieb am 12.08.10 14:42:40
      Beitrag Nr. 111 ()
      der meinte link please, hatte wohl noch dicke shorts im ärmel
      Avatar
      schrieb am 12.08.10 16:00:23
      Beitrag Nr. 112 ()
      Zu dem Artikel im "Aktionär" gibt es keinen link, der erschien in der vorletzten Printausgabe mit dem Titel "Die nächste Dendreon?"

      ...das Unternehmen hat mit Allovectin-7 ebenfalls einen Krebsimpfstoff in der Pipline. Das Mittel... durchläuftderzeit die dritte und entscheidende Phase klinischer Studien. Die Testes an 390 Patienten sind bislang erfolgreich verlaufen... Finale Daten werden für Mitte kommenden Jahres erwartet...

      Nur einige Auszüge daraus.
      Avatar
      schrieb am 22.08.10 00:40:41
      Beitrag Nr. 113 ()
      Antwort auf Beitrag Nr.: 39.963.608 von LeBarbier am 11.08.10 09:33:50Ahorne meint mit Lesezeichen, das er diesen Threat
      unter seinen Favoriten abgespeichert hat.

      ixilon
      Avatar
      schrieb am 03.09.10 22:36:34
      Beitrag Nr. 114 ()
      die shorts sollten vorsichtig sein
      Avatar
      schrieb am 10.09.10 22:38:17
      Beitrag Nr. 115 ()
      Antwort auf Beitrag Nr.: 39.946.067 von LeBarbier am 07.08.10 09:05:23
      Die Jungs hier sind nicht so gesprächig, liegt wahrscheinlich daran, dass z.Z. auch nicht viel zu sagen ist. Kursrelevante Daten kommen laut dem Artikel aus den aktuellen "Aktionär" erst Mitte nächsten Jahres.

      Nein, sehr wahrscheinlich kommen diese kursrelevanten Daten schon am Dienstag. Erst die fast banal erscheinende Pressemeldung, dass Vical die klinischen Ergebnisse der abgeschlossenen Phase II für den Wirkstoff TransVax präsentieren wird, dann der Hinweis, dass dieser Fachvortrag (nach Entscheidung des Veranstalters) ausgerechnet zur publikumswirksamsten Zeit bei der höchst renommierten 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, Boston -- September 12-15) angenommen wurde und dann der heutige Kursanstieg bei erhöhtem Aktienhandelsvolumen.
      4 Antworten
      Avatar
      schrieb am 16.09.10 17:31:53
      Beitrag Nr. 116 ()
      Antwort auf Beitrag Nr.: 40.135.410 von zeitreisen am 10.09.10 22:38:17Welchen Dienstag meinst Du?
      3 Antworten
      Avatar
      schrieb am 16.09.10 19:22:55
      Beitrag Nr. 117 ()
      Antwort auf Beitrag Nr.: 40.163.327 von LeBarbier am 16.09.10 17:31:53siehe News:

      url]http://ir.vical.com/releases.cfm[/url]

      see you
      2 Antworten
      Avatar
      schrieb am 16.09.10 19:23:36
      Beitrag Nr. 118 ()
      Antwort auf Beitrag Nr.: 40.164.084 von Ahorne am 16.09.10 19:22:55siehe News:

      http://ir.vical.com/releases.cfm

      see you
      1 Antwort
      Avatar
      schrieb am 22.09.10 15:28:07
      Beitrag Nr. 119 ()
      Antwort auf Beitrag Nr.: 40.164.090 von Ahorne am 16.09.10 19:23:36Ups was denn hier los???:eek:
      Avatar
      schrieb am 22.09.10 23:42:41
      Beitrag Nr. 120 ()
      meinen einstiegskurs macht keiner meht platt:laugh::laugh::laugh:
      2 Antworten
      Avatar
      schrieb am 23.09.10 17:46:53
      Beitrag Nr. 121 ()
      Antwort auf Beitrag Nr.: 40.195.661 von Kurumba am 22.09.10 23:42:41Weiss jemand was diesen Kursrutsch ausgelöst hat?
      1 Antwort
      Avatar
      schrieb am 23.09.10 20:46:33
      Beitrag Nr. 122 ()
      Antwort auf Beitrag Nr.: 40.200.157 von LeBarbier am 23.09.10 17:46:53
      Sanofi Aventis hat gestern gemeldet, dass ein von Vical unter dem Patronat von Sanofi Aventis entwickelter Wirkstoff in der klinischen Erprobung keine Wirkung gezeigt hat. Damit ist einer von vierzehn medizinischen Wirkstoffen, an denen Vical zur Zeit forscht und experimentiert wohl aus dem Rennen.
      Avatar
      schrieb am 25.09.10 00:27:20
      Beitrag Nr. 123 ()
      kapitalerhöhung 1.25$ pro aktie- mist
      Avatar
      schrieb am 05.10.10 12:36:17
      Beitrag Nr. 124 ()
      Vical Updates TransVax(TM) CMV Vaccine Program at World Vaccine Congress



      Press Release Source: Vical Incorporated On Tuesday October 5, 2010, 6:30 am


      LYON, France, Oct. 5, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that the company's Executive Vice President of Product Development, Alain P. Rolland, Pharm.D., Ph.D., is presenting detailed results from the company's recently completed Phase 2 trial of its TransVax(TM) therapeutic vaccine designed to control reactivation of cytomegalovirus (CMV) in transplant patients. Dr. Rolland is scheduled to present at 5:40 p.m. CEST today at the World Vaccine Congress (Lyon, France, October 4 -- 7).
      Avatar
      schrieb am 07.10.10 01:33:21
      Beitrag Nr. 125 ()
      egal- gute firma,wird sich schon berappeln
      Avatar
      schrieb am 07.10.10 12:51:24
      Beitrag Nr. 126 ()
      NEWS !

      Vical to Manufacture DNA Vaccines for Advanced Development by HIV Consortium



      Press Release Source: Vical Incorporated On Thursday October 7, 2010, 6:30 am


      SAN DIEGO, Oct. 7, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that the company has agreed to manufacture plasmid DNA (pDNA) vaccines against HIV under a $2.4 million contract with the IPPOX Foundation, a collaborating institution for the Poxvirus Vaccine Regimen Design (PVRD) led by the Centre Hospitalier Universitaire Vaudois (CHUV) under the auspices of the Collaboration for AIDS Vaccine Discovery (CAVD).



      A pDNA prime/poxvirus boost vaccine approach has been developed since 1998 by the EuroVacc program and currently the focus of the CAVD's Poxvirus T-cell Vaccine Discovery Consortium. The DNA/poxvirus approach has been tested in multiple Phase 1 and 2 clinical trials in Europe and has shown to be highly immunogenic. The current project is investigating whether the 2nd generation DNA/poxvirus vaccine approach combined with novel immunization strategies can induce increased and balanced Env, Gag, Pol and Nef HIV-1-specific T-cell responses in humans. Successful outcomes in the human studies could lead to further clinical development of the DNA and poxvirus vaccine candidates in Africa.


      Vical will produce individual plasmids encoding selected portions of the Env and Gag antigens, and one plasmid encoding selected portions of the Pol and Nef antigens. These plasmids will be combined and delivered as a single vaccine. Delivery is expected to be completed in the fourth quarter of 2010.
      Avatar
      schrieb am 08.10.10 10:14:48
      Beitrag Nr. 127 ()
      Avatar
      schrieb am 04.11.10 22:31:19
      Beitrag Nr. 128 ()
      in den USA steigt sie -und hier wird noch verkauft - lächerlich
      Avatar
      schrieb am 14.12.10 13:21:49
      Beitrag Nr. 129 ()
      Vical's Vaxfectin(R) Demonstrates Potential as "Universal" Adjuvant

      13 Dec 2010


      Vical Incorporated announced that the company's Vaxfectin(R) adjuvant has significantly boosted the immune response of DNA-based vaccines against a range of pathogens and cancer in preclinical models from rodents to non-human primates

      SAN DIEGO, CA, USA | December 13, 2010 | Vical Incorporated (Nasdaq:VICL - News) announced today that the company's Vaxfectin(R) adjuvant has significantly boosted the immune response of DNA-based vaccines against a range of pathogens and cancer in preclinical models from rodents to non-human primates. Vaxfectin(R) has demonstrated similar effects with protein- and peptide-based vaccines in preclinical models. Vaxfectin(R)-formulated H5N1 influenza DNA vaccines were well-tolerated and elicited durable immune responses within the predicted protective range in initial human studies.

      "Vaxfectin(R) has many of the desired features of a successful adjuvant," said Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development, "including the ability to significantly improve immune responses and favor specific types of immune responses. With a promising safety profile in preclinical and initial clinical studies, ease of formulation, stability and low manufacturing costs, Vaxfectin(R) is well-positioned as a potential 'universal' adjuvant for either immune enhancement or dose sparing applications in a broad range of infectious disease and cancer vaccines. A comprehensive new review of Vaxfectin(R) results published in the journal Expert Opinion on Drug Delivery[1] details Vaxfectin(R)'s development to date and should help us expand our outreach to potential licensees."

      Vaxfectin(R) has been shown in multiple animal models to significantly increase the antibody and T-cell immune responses to antigens expressed from plasmid DNA vaccines. Results from two Phase 1 clinical trials of Vaxfectin(R)-formulated H5N1 influenza DNA vaccines demonstrated strong antibody responses and achieved T-cell responses in 75% to 100% of subjects in various dose cohorts. Vaxfectin(R) has demonstrated similar effect with protein-based vaccines, and the formulation can be adjusted to favor specific immune responses. The current publication reviews non-clinical immunological and efficacy studies of Vaxfectin(R) in several infectious disease and cancer models, preclinical safety and toxicology studies, clinical development of Vaxfectin(R)-formulated DNA vaccines, and studies of Vaxfectin(R)'s mechanism of action.



      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      SOURCE: Vical Incorporated
      Avatar
      schrieb am 14.12.10 13:22:46
      Beitrag Nr. 130 ()
      hier eine etwas ältere Empfehlung:

      30.08., 11:14 GLOBAL BIOTECH INVESTING

      Vical könnte zum echten Homerun werden


      Endingen (aktiencheck.de AG) - Die Experten von "Global Biotech Investing" empfehlen Anlegern bei der Aktie von Vical (ISIN US9256021042/ WKN 886867) erste Positionen aufzubauen.

      Das Biotech-Unternehmen Vical sei im Bereich neuer Krebstherapien tätig. Das Medikament Allovectin-7, das in der Behandlung von metastierenden Melanomen Verwendung finden solle, sei derzeit der größte Hoffnungsträger in der Produktpipeline der Gesellschaft.

      In den bisherigen klinischen Phase I/II Studien sei mit dem Präparat eine durchschnittliche Überlebenszeit der Patienten von 18,8 Monaten erreicht worden, was bis zu dreimal länger gewesen sei als mit den heute verfügbaren Therapien.

      Daher sei es nicht verwunderlich, dass Branchenkenner dem Wirkstoff bei einem erfolgreichen Abschluss der Forschungsreihen und einer späteren Zulassung ein Multi-Milliarden-USD-Potenzial auf die Fahnen schreiben würden. Sollte Allovectin-7 zugelassen werden, werde Vical nach Einschätzung der Experten zu einem echten Homerun.

      Anleger, die nach der Erstcoverage der Vical-Aktie vor 14 Tagen noch nicht zugegriffen haben, sollten nun damit beginnen, sich erste Positionen dieses potenziellen Highflyers ins Depot zu holen, raten die Experten von "Global Biotech Investing". (Ausgabe 17 vom 30.08.2010) (30.08.2010/ac/a/a)

      Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.
      Avatar
      schrieb am 19.12.10 16:25:14
      Beitrag Nr. 131 ()
      jetzt schau mal, was nach der empfehlung passiert ist - massiv sind hedgefonds eingestiegen
      Avatar
      schrieb am 30.01.11 21:11:29
      Beitrag Nr. 132 ()
      Publication Highlights Allovectin-7® Phase 2 Safety and Efficacy Results in Melanoma

      01/11/2011

      SAN DIEGO, Jan. 11, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced a new publication summarizing results from the company's completed trials of Allovectin-7® including systemic responses and an excellent safety profile in patients with metastatic melanoma. An article published in the January issue of Immunotherapy1 noted that the U.S. incidence of melanoma is increasing rapidly, that current therapies are inadequate and toxic, and that melanoma is responsive to immune-stimulating drugs like Allovectin-7®. A Phase 3 trial evaluating the safety and efficacy of Allovectin-7® compared with standard chemotherapy is expected to complete final follow-ups later this year.

      The most recently completed Phase 2 trial was a single-arm, open-label study in which 127 chemo-refractory or chemo-intolerant subjects were treated with high-dose Allovectin-7®. There were no treatment-related Grade 3 or Grade 4 adverse events, and no withdrawals from the trial for tolerability. The overall response rate for the 127 patients receiving the high-dose treatment was 11.8%, with 4 complete responders and 11 partial responders. The median duration of response was 13.8 months and median survival was 18.8 months. These data compare favorably against historical controls from other studies in metastatic melanoma.

      Findings from the Phase 2 trial were incorporated into the design of a Phase 3 pivotal trial through a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA):

      * The Phase 3 trial sought patients likely to have functional immune systems.

      * Vical's Phase 3 trial was among the first for metastatic melanoma to exclude patients with elevated levels of lactate dehydrogenase (LDH), a key biomarker predictive of prognosis.
      * The trial excluded patients previously treated with chemotherapy.

      * The Phase 3 trial sought patients healthy enough to remain on study for at least two 8-week treatment cycles, the median time to response in the Phase 2 study.

      * The trial excluded patients with metastases to the brain or liver.
      * Response Evaluation Criteria In Solid Tumors (RECIST) standards were modified for the Phase 3 protocol to allow treatment continuation through two cycles at the physician's discretion, even if patients develop new melanoma lesions within defined limits.

      * Vical's Phase 3 trial was designed to capture the long-term benefits of immunotherapy compared with chemotherapy, as all responses in the Phase 2 trial were durable (= 6 months).

      * The primary endpoint compares overall response rates at 24 weeks or more after randomization.
      * The study will also evaluate survival as well as safety and tolerability.

      The Phase 3 trial, initiated in January 2007, is evaluating Allovectin-7® as first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. Vical completed enrollment in February 2010 of approximately 390 chemo-naive patients randomized on a 2:1 basis: approximately 260 for treatment with Allovectin-7® and approximately 130 for treatment with either dacarbazine or temozolomide. The company expects to complete patient follow-up and lock the Phase 3 clinical trial database in the second half of 2011.

      Allovectin-7® is a novel gene-based immunotherapeutic with a unique mechanism of action that is fundamentally different from currently approved treatments, and has the potential to be the first new primary treatment approved for metastatic melanoma in nearly 20 years. Vical estimates that the worldwide market for Allovectin-7® as a treatment for metastatic melanoma could exceed $500 million annually, and applications for other types of cancer could further expand its total use.

      Because the mechanism of action for Allovectin-7® is not melanoma-specific, it has the potential to be used in other types of solid tumors. AnGes MG, Inc., has licensed rights to commercialize Allovectin-7® in specified Asian countries, and is primarily interested in developing Allovectin-7® as a treatment for head and neck cancer, which presents a significant unmet medical need in Asia. Allovectin-7® is still available for licensing in North America, Europe and other regions.

      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.
      Avatar
      schrieb am 31.01.11 23:31:05
      Beitrag Nr. 133 ()
      die AMIS sind aber blind-sie sehen nicht, welches kleinod sie da besitzen
      Avatar
      schrieb am 14.02.11 22:34:39
      Beitrag Nr. 134 ()
      mmmmmmmmmmmmmmmmmmmmm:p:p:p:p:p:p:p:p:p:p
      Avatar
      schrieb am 25.02.11 23:37:39
      Beitrag Nr. 135 ()
      ...doch langsam werden sie wach
      1 Antwort
      Avatar
      schrieb am 30.03.11 12:36:41
      Beitrag Nr. 136 ()
      Antwort auf Beitrag Nr.: 41.110.474 von Kurumba am 25.02.11 23:37:39Schon Bekannt?:eek:

      Vical Is Deeply Undervalued: Technology and Pipeline Offer Upside Reward

      http://seekingalpha.com/article/260615-vical-is-deeply-under…

      Handel Heute in FRA

      Geld 1,891
      Brief 2,007
      Zeit 30.03.1112:07
      Spread 5,78%
      Geld Stk. 800
      Brief Stk. 800
      Avatar
      schrieb am 31.03.11 14:41:23
      Beitrag Nr. 137 ()
      ja, kenn ich - müssen langsam drauf hören, die shortplayer
      Avatar
      schrieb am 11.04.11 10:58:48
      Beitrag Nr. 138 ()
      ich war hier sooo lannge investiert und bin vor einigen Wochen mit kleinen Gewinnen ausgestiegen, weil ich keinen langen Atem mehr hatte. Seither steigt der Kurs, wie ich es vorher gern gesehen hätte.

      sehr ärgerlich, aber jetzt geh ich nicht rein, was ich vielleicht bereuen könnte
      Avatar
      schrieb am 17.04.11 12:52:41
      Beitrag Nr. 139 ()
      Vical Announces Key European Patent for TransVax™ Cytomegalovirus Vaccine

      04/14/2011

      SAN DIEGO, April 14, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today the issuance of European Patent EP1587816, which extends coverage for TransVax™, the company's first-in-class therapeutic DNA vaccine designed to prevent reactivation of latent cytomegalovirus (CMV) or introduction of CMV through donor cells or tissues in transplant recipients.

      TransVax™ encodes the CMV glycoprotein B (gB) and phosphoprotein 65 (pp65) antigens, and is formulated with a poloxamer designed to enhance primarily a cellular immune response. Vical's TransVax™ vaccine has orphan drug designation for transplant patients. In September 2010, Vical announced encouraging results from a completed Phase 2 trial of the TransVax™ vaccine in patients undergoing hematopoietic stem cell transplants. The company is currently in discussions with regulatory authorities to confirm the design of a planned Phase 3 trial which is expected to begin in the second half of 2011.

      Past development by others of protein-based prophylactic CMV vaccines has focused on antibody-mediated immune responses against the CMV gB antigen, which has achieved up to 50% protective efficacy. The new '816 patent covers DNA vaccines containing codon-optimized versions of genes encoding gB and CMV pp65 antigens, formulated with the CRL-1005 poloxamer in-licensed by Vical. It adds to Vical's family of patents in key geographic regions based on the company's discovery that administering genetic sequences such as DNA or RNA into the body, without the use of viral delivery vehicles, may cause expression of the proteins encoded by the genetic sequences. Vical has additional issued patents covering enhancements, manufacturing, and specific applications of its core technology.

      About CMV

      CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. While a healthy immune system typically protects an infected person against CMV disease, it rarely succeeds in eliminating the infection, and those whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death. Those at greatest risk include transplant patients and infants born to mothers who first become infected during pregnancy. Vical is pursuing two different vaccine approaches for these distinct market segments.

      CMV affects 30% to 60% of patients undergoing transplant procedures, causing transplant rejection, serious illness and even death if untreated. Expensive and toxic antiviral drug therapy is used to control the disease, but does not eliminate the infection. There is no approved vaccine against CMV. Protein-based vaccines that predominantly result in antibody responses to CMV may have limited effectiveness in transplant patients. Live, attenuated vaccines can induce both antibody and cellular immune responses, but pose a potential safety concern, particularly for immunocompromised patients, of causing the disease they are intended to prevent.

      Website: www.vical.com
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      schrieb am 29.04.11 17:05:50
      Beitrag Nr. 140 ()
      Vical Announces Encouraging H1N1 Pandemic Influenza Vaccine Phase 1 Results

      04/27/2011

      SAN DIEGO, April 27, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that more than half of the subjects in the Phase 1 trial of the company's Vaxfectin®-formulated vaccine for H1N1 pandemic influenza generated neutralizing antibodies of the type expected to provide protection against the disease. The vaccine was well-tolerated. Vical was the first company to manufacture a vaccine against the H1N1 influenza virus and the first to conduct animal testing during the 2009 outbreaks, and these latest results demonstrated the safety and immunogenicity of that same vaccine in humans.

      The trial was supported by U.S. government funding from the Defense Threat Reduction Agency and the U.S. Naval Medical Research Center (NMRC), and was conducted in collaboration with NMRC. Vical announced in February that it had extended its relationship with NMRC to develop the company's platform technology for the rapid development and production of vaccines against emerging infectious diseases. With additional funding under the extended relationship, Vical will work with NMRC under this contract to establish systems and procedures for the application of Vical's DNA delivery technology, with the goal of protecting military personnel from the threat of new pathogens in the early stages of outbreaks.

      "We clearly demonstrated the speed and safety of our approach during the 2009 H1N1 pandemic influenza outbreaks," said Larry R. Smith, Ph.D., Vical's Vice President of Vaccine Research. "The encouraging results of our Phase 1 clinical testing of our H1N1 vaccine, coupled with the successful Phase 1 clinical testing of our H5N1 avian-origin influenza vaccine, provide further validation for both our vaccine platform and our Vaxfectin® adjuvant. Through our collaboration with NMRC, we are working toward establishing an emerging disease vaccine platform to provide rapid protection against novel pathogens, initially for military personnel and eventually for the broader population."

      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

      This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Risks and uncertainties include whether Vical will receive all, if any, of the U.S. government funding; whether funding will be sufficient to complete the planned preparatory efforts; whether Vical or others will continue development of any emerging disease vaccine candidates; whether the company's Vaxfectin® adjuvant will be used in any future vaccine candidates; whether future infectious diseases will emerge, and if so, whether DNA vaccines will be successfully applied against them; whether any other DNA vaccine candidates will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical will further extend its collaboration with the U.S. government; whether the neutralizing antibodies generated in the Phase 1 trial of the H1N1 vaccine will provide protection against the disease; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

      CONTACT: Alan R. Engbring
      (858) 646-1127
      Website: www.vical.com
      Avatar
      schrieb am 29.04.11 17:14:31
      Beitrag Nr. 141 ()
      Avatar
      schrieb am 29.04.11 20:11:00
      Beitrag Nr. 142 ()
      So und da ich vermutlich Alleinunterhalter bin, noch was zum lesen für das WE, aus Nov 2010 :cool:

      Vical Incorporated (VICL) Analyst and Investor Day Transcript November 09, 2010 5:00 pm ET

      Vijay Samant

      Welcome to Vical’s Unidentified Analyst Day. We have our Senior Members from Vical’s staffs here along with some distinguished speakers, so – and both members from the buy side and the sell side community.

      First of fall, I want to thank all of you for coming for this Analyst Day. I want to walk you briefly to the agenda, but before I do that, I need to remind you of the Safe Harbor statements, you know, the presentation that both the outside speakers, as well as the inside speakers will be making – it may contain statements which are forward-looking statement. Please refer to our filed SEC document to fully understand the risk associated than investing in Vical or any of the biotech company for that matter.

      Brief overview of the agenda. I’ll give you a brief overview. The last time we did this quite a few people came that we directly went into the programmatic review and not giving a Vical overviews. So I’ll take about five minutes going to our broad programs that Vical has undertaken, beyond the two programs that we are focusing on.

      Dr. Sanjiv Agarwala, Sanjiv raise your hand please. He’s a distinguish melanoma expert. And he also is from Mumbai, which I just found out today. And he’s going to be giving us a little update on the state of melanoma, what’s going on. And obviously you'll have opportunity to ask him questions, as it relates to some of the competitive activities that are going on in the feet of melanoma.

      Followed that Alain Rolland our Executive VP of Development. Alain, is going to give a specific presentation on Allovectin-7, which will contrast some of the things that Sanjiv is going to be presenting, but will give you a real idea of what our program is and how the clinical trial is being conducted.

      Mark Pescovitz, is a leading transplant expert, solid organ transplant expert. And some of you may be familiar with him because he has been on some of our conference calls on the back stand, he’ll be talking about CMV, the State of Art of CMV and how important viral node in terms of predicting CB [ph] disease among other things.

      And Rick Kenney our VP of Clinical will be talking about our TransVax program, specifically how the clinical trial that we conducted recently, to summarize the data in what our plans for the future are. And then we’ll end the presentation with certain Q&As, okay, so which I would be moderating.

      So briefly quickly looking at Vical at a glance, it’s a late stage buyback company. 0We have multiple programs, cancer being the lead program, programs in infection disease, PAD. And established platform to be able to retain commercial rights to most of our program, we have several validating partnership, big pharma, small pharma.

      We are one of the few companies which has a State of the Art manufacturing facility and a strong balance sheet. The key program of Allovectin-7, big commercial opportunity, market greater than $500 million, CMV is the only company working in that field. Temusi, you will see the top line data on November 16, but that did not mean the primarily end-point and then emerging to this platform.

      Allovectin-7 is a first in class the systemic immunotherapy. We have dose about 800 patients to date. It has applications in variety of solid tumor. It’s well tolerated. Given an outpatient setting, it has unique mechanism of action. It’s synergistic with current program that are under development.

      And we have significant capacity to commercially launch this product, as I told you we are the only company we has to my knowledge of biological. The 13, San Diego, it is an often drug status. It has a fast track designation and it has – we have retained all the U.S. and EU rights for this program.

      TransVax to my knowledge, we are the only company working in the field of 90% to 40% of transplant with the safety vaccine, this is the therapeutic vaccine to prevent CMV reactivation, we have demonstrated group of concept in the phase II study that Rick is going to cover in details, all the clinical data which is presented at recently at AGAC.

      Again, we have sufficient capacity to commercially launch this product, we have often drug designation this is application of a both solid organ transplant and hematopoietic cell transplant. And it gets the rise both for U.S. and EU and you got to hear more about the clinical trial designs for both the programs, then Alain and Rick presents their respective presentation.

      Our key collaborations on AnGes is a second largest biotech company in Japan, they funded our melanoma program for Allovectin-7, pay us about $23 million for which we give them rise in Asia. And the goal really is use to Allovectin-7 in head and neck cancer in that part of the world. We have retained U.S. and European rights. I mentioned Collategene, which is the program for PAD, similar to the program that Sanofi is doing for PAD and they expect to start the trial sometime in 2011.

      Sanofi-Aventis obviously, will be very disappointed with the failure of that study; more of the data will be presented at the America Heart Association next week. And then Merck which has been a big partner for us has stated about $30 million for the last seven year has hTERT cancer vaccine which is a telomerase gene license from John [ph].

      How do you define validation of this technology? A lot of people ask, the two important validation that have occurred of for – in the animal health space, one is Merial lead of license incept which is the melanoma vaccine for dog. And this is really the first therapeutic vaccine approved before Dendreon’s Provench [ph] got approved either in human kind or fat kind.

      And it’s a – despite at $1000 per treatment, it was launched in Jan of 2010 is being short supply, but we expect this particular opportunity further validating the application of Vical’s technology.

      Novartis is a vaccine for stem and approved $3 million efficient clinical trial and all the salmon, and if you had salmon, you had salmon tonight for dinner. Unfortunately, we’re not going to have salmon tonight. Salmon coming from Canada is vaccinated with more extreme vaccine. And then we have several programs if you have collaborated with IHN.

      For peace simplex we presented some very exciting data, HIV Ebola, WNV, SARS in the intercept time will not be touching those programs today, you can do to our websites, but those programs have got in funding to the total $240 [ph] to $50 million for the last several years.

      Financially, we raised about $32 million in September 2010, we have sufficient cash now to last through 2012 and we have milestone – potential milestone in royalty payments which have potential to fund further R&D. Since, summary the upcoming milestone that the full data of that fail through C-trail will be presented at the American Heart Association.

      The Swine Flu data which has come out sometime in the first quarter of 2011, by the way that study was funded by the U.S. maybe the database log for Allovectin-7 Phase III for melanoma is sometime in the second half of 2011, I’m hedging the exact timing because we need to have the appropriate man create and make sure the patients have progressed.

      TransVax Phase III HCT trial and the SOT trial, our goal is to start those in the second half of 2011. And AnGes our partner which is going to do a PAD study in critical (inaudible) in sometime in 2011.

      So if you’re looking for investing in Vical what are the important value drivers, it’s a proven technology platform there are two animal health products that would be approved right now. We have a phase III program, which is the more advance immunotherapy asset is available for licensing.

      A phase II study in TransVax, the first time somebody have shown in such an immune compromise spacious, that we can mould in and response and Rick is going to cover some of that data very shortly. A phase I dynamic influence of vaccine program, why is that program important, this could be an opportunity, forgetting money for department with decent for further validations of the technology and potential starts oiling from very specific users.

      The phase I CyMVectin program, this is really a big opportunity. We’re collecting for vaccine for female of child-bearing age, this is the last big target for our female of child-bearing age. Female will see me negative, who get CMV infection defrayment is a leading cause of birth defects due to an infection raising to U.S. cytologist.

      Just – the way (inaudible) use to be in the 50s and 60s, we owned a lot of intellectual property around both TransVax and CMV, we had an IND approved and hopefully we’ll get funding from a partner to start the study in the near future, to approve animal health program and fiscal responsibility. If you look in the last seven, eight years, we have managed our cash very effectively both in terms of programmatic usage, as well as bringing revenues from other sources.

      So with that, I’ll stop and pass the turnover to Dr. Agarwala. Sanjiv.

      Sanjiv Agarwala

      Thank you, Vijay. It’s a pleasure to be here. And I just want to, that you all know that I am Medical Oncologist that specializes in melanoma a very unique disease that I’ll try show you tonight.

      I’ll give you one note that I am an Investigator on Vical phase III trial, which is being completed of course and I have done Ad-hoc consulting for Vical in the past and have received research support and honor form Vical I did not own any stock in this company.

      So let’s talk about melanoma and this is really an overview of the disease, I don’t have any specific data obviously with Allovectin-7 to show you. But what I want to do is put in perspective in terms of this disease what are the un-net needs, how important is it and where things are going into seal, this is being very exciting time for melanoma actually with a lot of new things going on.

      So 2010 these numbers go up every year, the U.S. incidence is now about 68,000 cases with almost 9,000 death and as I’ll show you, unfortunately the death rates for melanoma, approximates pretty much the number of stage four patient.

      The lifetime risk of developing melanoma is 155, which means if you know 55 people one of them will get melanoma, so this is a disease that although not as common as long and breath cancer so on, is very important and indeed by the way is the fastest growing cancer in both man and women today.

      These are some slides looking at some data that is some old and some relatively new. You see that the incident in melanoma is rising quite dramatically. And some of this is because we are looking for it more, obviously the more you look for something the more you find it.

      However, the debt rate has risen as well and it’s not just an artificial incidence because of increase awareness. This is now what we are projecting in 2015 that there will be one in 50 lifetime risk in the United State of melanoma in Caucasians and I got a feeling that that’s going to be exceeded, actually the way things are going. So we’re seeing much more this disease and we use to.

      Now, I do a lot of teaching for fellows and residents and so on. And of course, you have the stage cancers and I think just to make it as simple as possible as I do for them. I tell everyone that there are four stages of all cancer.

      So stage one and two is when it’s localized to the organ of Oregon, so melanoma it’s on the skin and not anywhere else, because that’s where it usually starts, it is a stage one or two. If it goes to the closest lymph nodes, the lymph plants that makes to stage three and anything beyond that is stage four. And this applies to most cancers.

      Now this looks a little complicated because what I’ve shown here is stage one and two in melanoma and then the key system we use a TNM system of staging for cancer to make it very precise. And T stands for Tumor size, N the word N, the letter N stand for nodes and M, of course for metastasis disease. So what is really shown here is that, you go from T1 to T4 and the stage goes up as the thickness of the melanoma goes up.

      I do want to point out that this is a cancer that we measure in millimeters there is no other cancer that we measure in millimeter. And to put in a perspective the four millimeter melanoma, which is not very large at all, the survival for that patient who has that melanoma can be as bad as only 50% that person is a 50% chance of making it for 10 years and there is no other cancer that does that for four millimeter of tumor.

      So very unique disease and therefore, what you have here is increasing stage and then, there’s something call isolation which is on the skin surface when the melanoma is isolated is worst and that’s why you have the AMB subset. So take one point, T1 to T4 goes from thin to thick, thick is four millimeters only and the stage gets worst as it grow along.

      Now looking at Nodal disease, this looks complicated too, but we know that when it goes to lymph nodes, the lymph plant and say for example, the melanoma is on the arm where it’s going to go is most likely the lymph nodes under the arm or the axilla, it can be involved, but it can be involved in various ways, it could be microscopically involved, which means that when I examine my patient I don’t feel anything.

      but I can find that microscopic node by new technique that we use called lymph node mapping and it can be very, very tiny but obviously if you detected that early it’s better, so that you have your, what we call N1 disease which is microscopic and AHS meaning that is very small and microscopic, macro means that I can palpate that lymph node, I can feel it and as you can imagine if I can feel it. There’s a lot of melanoma.

      And that make it worst, since – basically what it shown here is that ego from 3A, 3B, 3C depending upon how many lymph nodes were involved and how much involvement is there. Okay. So if I see a patient with lots of lymph nodes involved that’s much worst and somebody who I think there are no lymph nodes involved, but I do a special surgical technique and find that microscopic lymph node and of course, our goal is to find it as early as possible, because that’s our best chance to cure. So that’s your stage three disease.

      And then stage four. It’s kind of wide, if you think about it, right, because if it’s beyond the lymph nodes it could be anywhere, including the brain which is very bad as you can imagine. And it could in melanoma very commonly can spread to other skins sites, so this is not a new melanoma, but it goes from here to this side of the skin that becomes stage four.

      And as you’ll see in the other Vical study that was done, those were patient that were targeted for this type of approach. Its can metastatize the subcutaneous tissue that is underneath the skin and lymph nodes but they are not the closest lymph nodes but far away and a lot of people get confused by this. If you have a melanoma on the right arm and my left lymph nodes are involved get backs to stage four, not stage three.

      We also know that, we have the reason to subset this out is that, A) having these area is better than B, having it into lung and C is the worst which is having it anywhere else, which includes the liver, the bone et cetera but also keep in mind, if you read about this, there’s something called LDH and that’s importantly we talk about the trial having a high LDH no matter where the melanoma had gone to, if it’s that bad mark for melanoma.

      We know that now it’s very important. And we are to stratify patient based upon these and decide upon creeping options and clinical trial options of these patient. So we take one point that all stage poor disease is not the same, obviously there are categories within that subset as well.

      So what do we do, I’m a medical oncologist and my best friend is my pathogen because he is the one that is really going to diagnose the patient for me and hopefully cure that patient and I don’t need to do anything more. Unfortunately that’s not always the case, in fact it’s not often the case many melanoma patients don’t’ get cured by bioscopy.

      The first thing you have to do is, if you suspect the skin cancer, skin cancer are common, melanoma is one of the skin cancer is much less common but it’s very tough to diagnose it and I am very grateful that as a medical oncologist I don’t have to make this diagnosis.

      It should be simple right, because you don’t – you do not need a bronchoscopy or colonoscopy to diagnose melanoma. You should be able to look at it on the skin and pick it up. It’s not as easy as that. So you can suspect something and it won’t go there and miss the time, but the only way we can prove diagnosis is with the bioscopy.

      So if you get a skin lesion you don’t like, what you’re going to do. You’re going to make an appointment with your doctor and he’s going to look at it, if he doesn’t like he will bioscopy it. He will take it out as much as he can and sent it to the lab for analysis, if it is a melanoma and it needs certain criteria we do that lymph node mapping technique that I talked about which is – when I don’t have lymph nodes that I can feel, I am going to try to find it, anyway if it’s there – if it’s there microscope would do lymph node mapping and then if you made the diagnosis you take off little margin of skin around that to be safe that a wide excision and then if the lymph node is positive, you take the rest of the lymph nodes out.

      So this is our surgical approach and my surgeons that we work with will do this very nicely and then after that’s all done, we have the right stage and then I get involved in terms of what else we can do next.

      And where I get involved with these patient that are hopefully cured but sometime not is perhaps give them what we call adjuvant therapy. You have heard about this, this is another cancer treatment given post surgery to try to prevent relapse and therefore make the patient live longer.

      So we know that when you take cancers out no matter what they are, they often come back, just because it could be microscopic cell that’s gotten away, we can’t find them. So we sometimes get chemotherapy and so on in melanoma, the only drug that has worked and will tell you that it’s not worked as well as we would like because it has this problem. But this is an approved agent, IFN-alpha [ph] use a lot of this.

      It’s immune therapy, I do want to point out this because one of the unique things about melanoma is that immune system is very important and indeed the only adjuvant drug in melanoma that’s approved or works is an immune agent, not a chemotherapy. Chemotherapy in fact in the adjuvant setting in melanoma is useless, everything else has not been effective. We won’t go there in terms of details, but we tried everything including radiation and so on it doesn’t really work.

      So let’s now talk about metastatic melanoma which is of course the main interest, right, because that’s where we have a major (inaudible) and just to summarize here the four approaches that we take as clinician and researchers for treatment in melanoma, we can try chemotherapy, we can try immunotherapy, biotherapy is the other name for that. We can put altogether and have chemoimmunotherapy, so we try everything because it’s kind of desperation to get something that works and of course, experimental treatments, clinical trial which is certainly a very important approach for this disease.

      Let’s start with number one, chemotherapy. So this may be a little hard to read but bottom line is that there are some chemotherapy drugs that have been applied in melanoma, you might have heard of dacarbazine or DTIC. It was approved by the FDA about 30 plus years ago and if you look at how often it works, we use this terminology CRPR which mean complete response, all tumor gone, partial response, tumor shrunk by seven percentage.

      That combination has been reported to be about 20% and keep that number in mind as I show you in the next slide but everything else that has been used, none of this are FDA approved drugs melanoma by the way apart from DTIC but we tried them anyway the numbers are small and had not really been any better than DTIC.

      The problem is that DTIC which is the only FDA approved chemotherapy drug from melanoma after 30 plus years and I have been doing this now for 17 years, there’s not being a new drug approved for chemotherapy melanoma. The response rates that mean the percentage of patients that have a meaningful shrinkage of their tumor is not 20% as you thought. It in fact is lower than that, it is single digit number, 6.8% in one study,7.5 in the other because the date I showed in the previous slide was older, now we have much more straight criteria, CT scan and so on, this does not work very well, that’s important.

      And the important things is also it doesn’t last very long even if the 20% or less in this studies that’s a 10% doesn’t last very long and in fact the medium time to progression which is, we called this, when does the patient progress on their CAT scan, we tend to scan our patient every two months and the medium time that means some more like the average time, that the patient progressing is less than two months, which means that when I give somebody DTIC and it shrinks, the tumor shrinks, chances are the next time I scan them it’s progressing and that’s obviously the problem.

      Survival this is median number in our fact rate. So this is – these are the facts about our only chemotherapy approved drug by the FDA. It is still the standard drug, response rate is really less than 10%, one and 10 not very good. Importantly, no long term remissions. We don’t have durable responses from this. And you know to be very fair this drug has never been tested in our clinical trial versus doing nothing, or doing best supportive care.

      Of course, that trial is impossible to do, no patient going to be willing to go against that and many of us in the field take that DTIC is in fact that’s supportive care, it doesn’t do all that. And as I mentioned no new drugs approved and you know there is (inaudible) also to remember it’s very important that, the reason is there will be no drug approving chemotherapy is that, we have not yet beaten DTIC in the randomized study. Okay that’s very sober in fact that we have not yet beaten the struggle any randomized trial than anywhere in the world yet.

      So in oncology, when we have one drug that might work and other that might work as well, we often add them together. We get combination chemotherapy and one of the combination chemotherapy is it goes by the name of the Dartmouth regiment, because it came out Dartmouth.

      Just to summarize, I feel four drug added together, they all have activity. I think, I can go in a detail afterwards if you like but bottom-line is this combination we thought was going to be better, so to prove it, you do a randomize trial four drugs versus one. You could imagine how difficult that trial was to do in terms of just getting patients to agree to it, because everyone has tendency to think more is better, indeed more is not better. This is an example of a Keppler-Meier survivor curve where the two arms of the trial completely overlap and both go down close to zero essentially one important fact of chemotherapy melanoma is that, no matter how many drugs you put together, we have no better benefit then DTIC alone.

      So DTIC is still standing tall as the drug to beat in metastatic melanoma in terms of chemotherapy. You might have heard temozolomide and I mentioned temozolomide because it happens to be actually in terms of chemotherapy even more widely used from melanoma then DTIC even though is not FDA approved. The reason it’s widely used is because it’s very similar to dacarbazine or DTIC.

      It has some penetration to the brain which is an important place for melanoma to travel and its appeal it makes easy to give. So essentially there are couple of trials now showing you one here, that is looking at whether temozolomide which has all these potential advantages is it any better than DTIC. This is a large European trial that I actually participated in this as well as my center.

      We can see a very large sample size and the bottom line is that indeed the two drugs are basically equivalent. So the question is you know, temozolomide and DTIC are about the same and therefore are having the same information in terms of response rates. And as I showed you earlier not that great, we would love to have something that was better than DTIC or .dacarbazine.

      So to summarize chemotherapy, the standard drug is still their dacarbazine from the FDA approved drug. Temolozomide is no matter how you do it, which ever schedule you test, it’s about the same as DTIC, combination chemotherapy is not better than single agent chemotherapy and of course when you add drugs together, if you have no benefit you certainly have more toxicity. So we don’t recommend doing that, outside of any kind of clinical trial. So our standard treatment for melanoma right now, is we’re going to use chemotherapy using one drug, even though it sounds, less aggressive, it is indeed the right things to do.

      IL2 the other approved drug for metastatic known by the FDA is not a chemotherapy drug, it’s an immune therapy drug or biotherapy drug caused (inaudible), it came of the NCI of the National Cancer Institute, some taxable IL2 to summarize a complicated and long field. This is a high-dose treatment, to put in a perspective, it needs to be done mostly in the ICU, okay. This is not a treatment that is doable by anybody.

      You cannot read a book and give someone IL2. You have to be specially trained to do it. My center does it, there are only about 15 centers in the country that offer IL2 to patients and it’s a very expensive and toxic treatment, but the reason we do it is that there are some patients, a small number, about 5% to 6% for whatever reason, we don’t know how to select those patient ahead of time. They will respond to this drug and will remain responded for a durable amount of time.

      So what separates IL2 from chemotherapy, even though it’s very toxic and expensive and ICU and all that, is the durability of response and that’s the key things because finding something that works that’s less toxic and durable will be very, very important. And as I said earlier, it is something that is, only given to selective patient that has all these different side effects that you can imagine, low blood pressure, renal failure, swelling and so on, difficulty breathing.

      These are not things that most patients want to go through and indeed only 10% of people that we see or even candidates to get this and it works on 10% of them. So this is a one in 100 drug, really if you think about effectively.

      So let’s try to fill it all together. Let’s take IL2, let’s take chemotherapy and put them altogether and see if it that works any better. So there was this very large clinical trial that was done through the cooperate group ECOG mechanism that’s a group that all of us collaborate on and do studies together, and what this is really showing you is that there were three chemotherapy drugs and CBD is three drugs, Cisplatin, Vinblastine and dacarbazine or DTIC, so three chemotherapy drugs. IL2, not the high dose IL2 but a lower dose because we really cannot add high IL2 to anything and interferon as well.

      All five drugs, to cut a long story short, when we did the trials of the five drugs just in phase two, they look like it might be better, but you have to prove it, do a randomized study, the comparison was chemotherapy alone versus adding the biotherapy on the other arm and yet another negative clinical trial with very similar capital micros overlapping.

      And really if I just go back for a second here, combination chemotherapy is no better than single agent chemotherapy. So really if you had five drugs together including lower dose of IL2 and interferon, it is truly no better than single agent chemotherapy. So back to DTIC, as your kind of like goal standard, chemotherapy drug for melanoma.

      So let’s just summarize what we have available to us outside the clinical trial and what we would have approach as clinicians outside of the clinical trial. We would say that single agent chemotherapy is still the standard, but unfortunately, DTIC does not have the high response rate and more importantly, even though the people that respond, don’t respond for very long time, almost always they are progressing very quickly we need something else.

      High dose IL2 is a little bit different. It has durable responses, but as I said earlier, if the drug that is quite toxic and therefore it requires a very healthy patient that is able and willing to go through this that it’s only 10% of the people that we see. And if only one in 10 of those respond, you’re not looking at a big drug that is going to be taking over and doing a lot of things for a lot of people, something that is very selective.

      Adding the two type of treatments together and at some format like I showed you and there are other trials as well does not improve response rates, does not improve survival. All of these have some issues with toxicity and safety, and there was no question that this is a disease that in terms of career choices for us as oncologist are very good carrier choice, because there’s a lot of work to do. There is a major unmet need for new treatments in metastatic melanoma.

      So what are those new treatments that have been looked at, now this is a very simple collaboration of the cell, you know, when I was studying oncology, we were taught that the reason cancer flows, cancer survive is because cells are growing quickly. They’re rapidly dividing. They are growing fast and they are cumulating, we now know that in fact that’s not true, cancer cells actually grow slower than normal cells. They just don’t die. Cancer is a disease of lack of death not a disease of too much growth.

      And if our process [ph] which is death in cancer cells occurs normally in normal cells all the time and you have this path ways in place that makes the cancers cell to become a cancer cell by refusing to die, so you know when I teach my fellow I tell them that the way it work is, if you are a cell and you go into the cell cycle, which happens several times a day in some cells, you stop and you examine yourself and see, am I normal and if I’m normal I would say alive and if I’m not normal, I should really commit suicide and go away.

      That’s what a cell is supposed to do. When it does not do that, it becomes a cancer cell. It’s obviously a complicated mechanism in place that make it not do that. One of them is a pathway called B-raf and I’m sure you’ve heard of this pathway. And B-raf is a mutation, an activating mutation but the bottom line is what it does is that B-raf is mutated in melanoma.

      It makes the cell not die. It cuts off its apoptotic pathways and it’s mutated in about 40% or 50% or so melanomas, not every melanoma has that mutation. So wouldn’t it be nice if we could find a drug that targeted B-raf and therefore allows the cell to take up dose and therefore the cure the disease and clear [ph] the disease.

      So the first drug in that area was called Sorafenib. Sorafenib was in the market for kidney cancer and some other diseases as well. And this was a clinical trial and I won’t give you the details why but it was a chemotherapy combination with Sorafenib, placebo on one side, Sorafenib on the other, chemotherapy on both sides.

      This is a front-line trial that we did to ECOG. It’s not yet been published but it was presented in an abstract form, lot of study and what it showed was that the reason of course, Sorafenib was added to this was because Sorafenib has activity against B-raf turned up. We know now not so good activity and indeed you have overlapping survival curves once again.

      So adding Sorafenib into frontline setting for metastatic melanoma with that chemotherapy did actually nothing. So there was also a trial looking at second-line therapy. This is a trial that we presented at ASCO in 2007 and very similar design, in fact, this study was actually reported before the other one, second line trial, same design, Sorafenib on side, placebo on the other, chemotherapy combination and a second-line setting, exact thinking [ph], no benefit of Sorafenib

      So one of few things, either B-raf is no good in melanoma or Sorafenib is not a good B-raf drug. And we think it’s a matter because we have better data now from drugs that are more selective and highly effective in inhibiting B-raf, example being PLX4032, one of the drugs out there that has been, now this is, I just showed you the presented data, there is more updated data as well.

      So if you have B-raf mutation and you use a B-raf selective drug, you can get some nice responses. This is still being worked out, randomize studies are going on. I’m sure you are following this but it’s looking promising and we’re finally understanding that there might be some biology here in melanoma that we can exploit.

      So that’s a B-raf story in nutshell. What about anti-CTLA4 antibody therapy? Switching back to immunotherapy now, so the anti-CTLA4 pathway, the way I can look at it is that the CTLA4 mechanism and I won’t go in detail, is like a brake on the immune system. So we all have immune systems and the immune system is set up in a way that it works normally and they are check points in the immune system.

      CTLA4 is a brake. If you – anti-CTLA4 antibody takeaway is a brake. So the immune system gets hyperactive which is a good thing for creating melanoma but not so good for some side effects that can take place obviously. Ipilimumab is one of the anti-CTLA4 antibodies. This study was presented at ASCO and published recently as well as you can see here.

      This made it to the final session of ASCO so it is very exciting. It was a trial comparing Ipilimumab by a cell plus placebo to Ipi plus gp100 vaccine for the vaccine alone. That was a trial designed a randomize study, do want to point out here with second-line therapy, not frontline therapy.

      This has sample size of 600 plus patients and a three arm study and what really was seen was that the vaccine arm alone was inferior to both the other arms that really the comparison was designed and the statistics will be between Ipi plus placebo versus the gp100 and there was a significant difference.

      So for the first time, we had a randomized study in metastatic melanoma with a survival advantage. We never had that before whether it is second-line therapy and the median survival is approved for about six to 10 months. So it certainly not a cure for everybody but I think definitely a nice interacting advance that is validated with the concept with immune therapy melanoma is important. And there is no doubt that immune therapy melanoma is a key part of our therapeutic approach of the disease.

      Anything we do have side effects unfortunately. I do want to point out here that Ipilimumab does have side effects. The important thing is that if you look at what this drug does is make sure immune system hyperactive, we try to make you allergic to your melanoma but sometimes it makes you allergic to parts of yourself as well, which is why you get diarrhea and so on in terms of some other side effects. Okay. So there are some issues with this but obviously with better training and management, we will be able to control this and this is a powerful weapon.

      The question is how do you harness this to make it effective for yourself without doing harm to the patient and we have some more things to learn about that. So you know, having said that immune therapy is important, chemotherapy, obviously, I convinced you is not great. B-raf, we’ll see what happens is looking good but we will see. So let’s just spend the last couple of minutes on immune therapy.

      There is a couple of things that are very important about this approach. Immune therapy is not chemotherapy. These are not chemical. You are not giving someone a poison to kill the disease and obviously, has side effects with the patient as well.

      You are giving them a treatment that is trying to change their whole immune system. You are trying to making their normal immune cells more reactive and that takes time, if not something that you give a drug today, it is going to happen tomorrow. It can take weeks to months for that to happen. In fact, that’s a biggest problem with this approach is that you need sometime and we are impatient as physician and as patient and we are trained to do scans every two months and if we don’t have that response to two months, if that is not working, let’s move on.

      That’s not the case with some immune therapy. Just to wait a little bit longer, if you can, sometimes you can so the response might be delayed but the interesting thing is when they are delayed sometimes they are very durable so you should not miss this if you can. That’s important about our immune therapy. You often have mixed patterns of response.

      Most patients have more than one side of metastases. So I got two liver mets and one lungs mets, two mets underneath the skin and I’m giving some one immune therapy, you could have a response in one place and growth somewhere else and sometime all that comes together as being a response so we will do clinical trial however. You might know this, they are very strict.

      If you have a new lesion, no matter if you have five and all five are shrinking but number six shows up, that’s progression. You go off that treatment. For clinical and trial purposes, that is a failure and you have to move on. Is that the right thing to do? Who knows? Right. With immune therapy, you have to figure this out.

      So survival and durability response are much more important endpoints. So when we design clinical trials for immune therapy, we have to be careful. We cannot design that with the same patterns we have used for chemotherapy. We have to design them with a little different approach, allowing the patient to work to have that response perhaps seen.

      And that’s what we’re trying to show here is that chemo happens quickly, goes away quickly. Immune therapy happens slowly, sometimes later but it lasts longer and that’s the key that we are going to be designing immune therapy studies looking at durability. Just like IO2 for example, it’s important.

      So I hope I had some tendency [ph] that melanoma is unique. It is. Why is it unique? It is resistant to most forms of therapy. You know, there is not a cancer out there that has had such little success with chemo.

      Think about chemotherapy in breast and lung cancer, it works much better. Probably, it’s because we call melanoma by one name but its several diseases in one. And we’re learning that from the biology of heterogenous and we’re creating it all the same way. You can do that.

      You have to design studies and treatments for patients that has specific biology and finding the right person to enrich your population, if you will. It’s a difficult trial design. That’s exactly why all those negative survival occurs, I’ve showed you, it’s because the designing studies for those disease, especially with immune therapy are difficult and it’s very important when you have a disease that is technically incurable that quality of life is important.

      So there is no point in giving some high dose IL2 drugs because at the end of the day, the patient is going to die at exactly the same time. What service have I done to that patient? You got to find a treatment that allows them to continue life on in a more humane way and that’s very, very important.

      Melanoma is immuno responsive. No question, two of the three drugs have approved melanoma in a high dose IL2, the other is DTIC our immune therapy drug, no other cancer has that. We know that if you look at melanoma tumors, there is insufficient lymphocytes.

      Lymphocytes are trying to get in there. Something about this disease, it’s attracting them or something about this disease is making those lymphocytes angry and they want to get in, they’re going to attack it so how do we use that effectively. We know from many observations that Vitiligo has improved outcome.

      So when you have a patient with melanoma and I’m treating them and they are having the discoloration of that skin, they are very worried and I’m telling them that’s a good thing because your skin is being attacked by the same lymphocytes that are hopefully attacking your tumor. And of course, we do need additional approach to it as well. So thank you. I’ll stop here.

      Alain Rolland

      Just like to thank Dr. Agarwala for his excellent presentation on metastatic melanoma. I’m Alain, one of the Executive VP, Product Development, at Vical and I’m going to show you how we have developed novel immunotherapeutic for melanoma. Allovectin is Vical’s new product in the phase III of the trial. It is the first in class immunotherapeutic, currently validated in metastatic melanoma patients.

      Allovectin is plasmid bicistronic [ph] immunotherapeutic but expresses two genes which together form an MHC Class I complex. It is formulated with a proprietary lipid base system that actually placed the delivery of DNA into the strongest [ph] tumor cell. It is convenient to the patient of the single bio, stored refrigerated and we are using a conventional needle and syringe administration into a lesion.

      The initial development of Allovectin that I will review today is focused on metastatic melanoma but as immunotherapeutic, it could have essential applications in other accessible solid and immuno reactive tumors as well.

      Allovectin is injected into a single lesion to produce both a local but also a systemic effect through six weekly injection cycles. The point is used in a physician’s office as we heard from Vijay in an outpatient setting and it does not require any pre-medication or post-medications (inaudible) hydration.

      One of Allovectin’s hallmark has been the remarkable safety profile to date, observing multiple trials with multiple dosing as well. Allovectin has a unique set of mechanisms of action. Really does it teaches the immune system to recognize and destroy the tumor cells. First, the HLA-B7 flags the tumor cell aspirin [ph]; you know we’re very similar to the transplant mismatch.

      This is an immune reaction against these tumor cells. Then Beta-2 microglobulin also restores the effective presentation of the tumor associated antigens from the patient, making these tumor cells more visible to the immune system and finally, the lipid DNA complex that we are using induces danger signal that serves or boosts immune system against these tumor cells.

      So in another words, those different actions result in the local and a systemic recognition of the tumor cells by these educated immune cell. Allovectin mechanisms of actions is complementary and plus it would be synergistic to other anticancer therapies. We are very excited as we heard about the recent success of Provench [ph] for instance and Ipilimumab but combination was released as Dr. Agarwala pointed out, we like to remain the standard of care in oncology. So in the example shown on this slide, the T-cell activation generated by the anti-CTL4A antibodies such as Ipilimumab could work in concert with Allovectin-7 by boosting the tumor cell destructions by these T-cells that have been activated.

      The safety and the efficacy of Allovectin at high dose, the 2mg dose where if elevated in the phase II clinical trial, a very large phase II with a 127 patients, most of the greatest trial that we have done at Vical, we’re continuing with a much lower dose 10 mg dose which is about 20 times lower than the dose that we are using or we have used in phase II. The efficacy was evaluated in 127 stage three and stage four metastatic melanoma patients and several response endpoints were measured by strict RECIST criterion.

      Overall, survival also assessed in this phase II profile. Allovectin was very well tolerated as you can see on this slide, when compared to other treatment such as DTIC and Ipilimumab, the 11.8% response rate achieved with Allovectin-7 compared very favorably with these historical data with chemotherapy, for instance, such as DTIC or immunotherapies such as Ipilimumab, all the responders to Allovectin added durable response to at least six months as presented by Dr. Agarwala and have shown in the slide, chemotherapy results in a very short-lived response.

      For such kind of chemo naïve patients but we are finding in phase III, the double response rate was about 17%, so that’s highly remarkable. Importantly, in these last phase II clinical trials, the median survival was 18.8 months which is remarkable when you compare to historical data in metastatic melanoma population where the survival range is strictly from six to 11 months.

      In fact, this Kaplan-Meier graphs represents the very promising median survival of 18.8 months obtained with Allovectin-7. Even though a 63% of outpatient receive one cycle or less with Allovectin due to pervasive disease based on strict RECIST criteria at least half of the patient showed a substantial survival benefit compared to historical controls. The respondents in particular are prolonged survival ranging from 18 months to more than seven years and the median survivor as you can see on this graph was not even reached for the responders.

      We further compared Allovectin phase II survival data to recently published analysis of 42 phase II clinical trials in about 2000 metastatic melanoma patient. In this application, as shown on this graph, the mean one-year survival was 25%. No statistical difference was observed with any of these treatments since on this one-year survival points of these blue dots basically fall within the 95% confidence internal.

      In contrast, if you look at the Allovectin-7 one-year survival of 65%, this is well above the run showing a statistic of significant improvement in comparison to this historical data. Even the two-year survival of Allovectin which is 23% is still better than the one-year survival for all of this published data.

      So what did we learn from this phase II results in order to maximize this phase III design for the first line education. First, we selected the healthiest metastatic melanoma patient. We have normalized (inaudible) normal LDH, nor brain, no visceral mets, no liver mets and we also selected chemonaïve patient with more intact immune system and this to keep the patient on study as long as possible in order to maximize the chance of benefit from the immune therapy Allovectin-7.

      We injected a single lesion with a full dose 2 mg to optimize the antichemo effect. We also modified the RECIST criteria to help patient – to keep the patient on study for at least two cycle. Two cycle was the median time to respond in the phase II study. We also allowed resection of a stable lesion after 32 weeks to verify the lesion is median lesion or whether it is only scar tissue. And then we use as we heard from Dr. Agarwala the primary endpoint that we stated as durability of response observed for immune therapies.

      For the phase III pivotal trial design was accepted by the FDA under special protocol assessment and FDA. It is intended to show superiority of Allovectin. This is third-line chemotherapy, DTIC or temozolomide, the choice powered 90% at least to show benefit not only in response rate but also in survival benefit. The trial of enroll, 390 patients by February of this year due to a large number of subject (inaudible) both in the U.S. and Europe and AnGes (inaudible) Japan has truly funded the clinical cost of the phase III clinical trial.

      We expect as Vijay mentioned, to a lot of database in the second half of 2011 and surely there are, so we will announce (inaudible).

      So in summary, Allovectin is a first in class immunotherapeutic with a unique mechanism of action but is complementary to other anti-cancer therapies. Allovectin is used in an outpatient setting and has very safe profile. We have focused initially on metastatic melanoma but Allovectin has potential indication in all their solid tumors.

      We have obtained very promising results in this phase II clinical trial and pivotal phase III trial as completed the enrolment early this year. We have a pay notes to Orphan Drug designation and Fast Track designation in the U.S. And we’re now getting ready for commercialization of our reconciling. So I’d like to thank you. I think we are in transition now to drawbacks.

      Mark Pescovitz

      Okay. So we’re going to change gears entirely here. Go from cancer to infectious disease and talk about virus which is particularly problematic in transplantations of stem cell and solid organ called cytomegalovirus. But before I again, I should make a note that I’m a paid consultant of Vical. I have also received consulting reports and grants reports from Roche, Genentech and honorary from me to those. I do not have stock in Vical or for that matter in Roche and Genentech.

      So cytomegalovirus is a major problem in both solid organs and stem cell. There is about 60,000 allogeneic which means transplant from one individuals to another and autologous which means a transplant from the person back into himself. There is about 60,000 of those hematopoietic stem cell transplants or HCT done in United States and Europe each year.

      Similarly, there is about 60,000 allogeneic solid organ transplant so they are performed in both Europe and U.S. Cytomegalovirus has been and continuous to be perhaps most common opportunistic infection after transplantation, appearing in anywhere from 50% to 70% of patients, depending upon the specific combinations.

      I’ll show some of the data to support that and whether or not to use and what type of prophylaxis or preemptors strategy used. The incidence of clinical apparency on the disease is slightly less, anywhere from 20% to 60% but if we do not treat CMV than either the solid organ or the HCT population at least to a very high morbidity and mortality.

      When I talk about CMV, it’s a fairly simple life cycle shown here. In the center, there is a cartoon of the virus itself that’s a double stranded DNA virus which is surrounded by a capsid. When a patient first – a person first comes in contact with CMV, the CMV enters the host where the viral envelope binds to the cell, the viral DNA enters the nucleus of the cell, viral DNA replication occurs, virus particle are assembled and in this area here, an immune reaction starts to occur.

      And depending upon, how strong the immune reaction is one of two possible scenario is going to occur. Either the immune system is weak and this virus just keeps going around in a circle generating more viral particles and expanding exponentially, creating CMV disease. The patient gets sick or alternatively, an actually at the same time, the virus can enter what’s called the latent stage where the virus is in the body but not replicating and not causing disease.

      Now, when we make a diagnosis of CMV, (inaudible) clinical disease, we know the patient is sick but you also want to show evidence of the virus. And the original way of doing this was by culture such as the shell vial culture is very insensitive. It takes a long time and it’s pretty much relegated to the historical literature.

      Alternatively, you can measure CMV antigenemia and this is an assay where you take white blood cells from your particular patient, you spin it down onto a microscope slide and you stain using amino fluorescence for example against the polypeptide 65 or pp65 and you look to see whether or not there are any fluorescent cells indicating that there is a virally infected cell circulating in the blood. This is semi quantitative and is still used in a lot of centers.

      Now, we’re advancing more towards DNA methodology, you can use either qualitative preliminary chain reaction or PCR or a quantitative PCR to identify whether the virus is there and how much of the virus is there. So they are both very sensitive and if you actually quantify it, you can break them up into different risk groups, depending upon how many viral particles there are.

      And lastly, there are newer ways such as detection of mRNA for those who are not yet approved or being used widely. Now, the most important the predictor of who is going to develop CMV post transplant is what’s called serologic risk and serology means antibodies. So if a patient has antibodies before the transplant either a stem cell transplant or metastatic cell transplant or solid organ transplant and what the donor status is, puts the patient in a certain risk status.

      So these are data now from an HCT study and shown along the x-axis here is the days after transplantation and along the y-axis going up to here about 20% is the incidence to CMV disease. What you can see is if your donor of the bone marrow is negative and recipient is negative, there is no CMV in the system and obviously the risk of CMV is quite low. If the donor is positive and recipient is negative, there is now a little bit of incidence of CMV. But the worst is when the recipient is positive.

      Remember that virus is latent. You’ve eliminated the immune system but the virus is still sitting in the body. So when the immune system gets weakened, that virus is now able to replicate. Now, remember this image because in solid organ it’s flipped. Okay, now once again, the lowest risk is still the donor negative, recipient negative but the highest risk now is where the donor is positive and recipient is negative.

      In HCT, it was where the donor was positive or negative but the recipient was positive, that was the highest risk. Here, if the recipient is negative, that’s the highest risk because now these recipients are here have never had a chance to mount an immune reaction. So developing a primary infection to CMV in the phase of a very weakened immune system.

      If a donor is positive and the recipient is positive whether donor is negative and the recipient is positive, that was the highest risk with HCT when in fact, it’s an intermediate risk with solid organ transplant. So although virus is a same virus and the treatment is similar, you have to think in terms of different groups, in terms of risk factors.

      Now, when did CMD occur? Well, it occurs fairly early. Once again, this is time after stem cell transplant or HCT here. This is in days and this is out in months here and you can see that in – Viremia is occurring fairly early at about 40 days. And that’s pretty standard. But if you don’t use any sort of prophylaxis, you’ll start to see Viremia developing at about 40 days or so. It used to be called the 40-day fever because that’s why it was happening, you get a fever of about 40 days.

      Furthermore, you will notice at the incident of Viremia is relatively high in this population, about 50%. Now, on the other hand, if you don’t do anything and you progress the disease, the disease is going to happen a little bit later here at month and the incident to disease is much lower than the incidents of Viremia. Now, why is that, that’s happening because we typically don’t want lot of these patients go to disease so we start interrupting. When they have Viremia, we start treating and that lowers the incidents of disease.

      Now, in the stem cell or hematopoietic population, if you have T-cells still around, if you have an intact system, so a non-myeloablative, you can see as the time the CMV disease is actually delayed. Here it is later than if you deplete the immune system. So in a myeloablative, we wipe out the immune system completely, CMV disease is happening very early in a non-myeloablative approach, disease happens later.

      Now, in organ transplantation, the same sort of pattern appears. These are data from an early trial and liver transplants where the patients did not receive. This is placebo group. They did not receive any anti CMV prophylaxis along the x-axis against the time for its transplant and you can see that once again the time to CMV is at about 40 days.

      So again, solid organs, similar to hematocellular transplant patient, if you don’t prophylax, CMV is going to happen in about 40 days or so.

      Now, why bother worrying about CMV, well there is a lot of reasons too and it causes a lot of different types of disease processes. First of all, we can develop what is called CMV syndrome and CMV syndrome is the fever that people get. Typically, a spiking fever goes up, comes back down. In my response, it was administering aspirin but the patients feel quite miserable. Lot of malaise, well they are febrile.

      Back in progress, we’ve got tissue invasive CMV disease where the virus actually gets into organs and effects them and can cause a gastroenteritis in the stomach, intestine and colon, which can cause symptoms such as heartburn which doesn’t respond to an H2 blocker. In worst case scenario, that can actually lead to a perforation of the stomach or an intestine which can lead the need for an emergent operation.

      It can lead to nephritis or an inflammation of the kidney which can look a lot like rejection, it can lead to hepatitis which can cause liver enzymes to be elevated. It can cause pneumonitis such as shown here and if you don’t give any prophylaxis, pneumonitis can lead to the patient requiring ventilator support and can actual result in the death of the patient.

      And lastly, CMV retinitis, more common in the HIV population but still can occur in organ transplant and HCT. There is also a host of what we call the secondary complications or CMV and this is where you can really identify the virus but there is a strong association between the presence of the virus or the presence of the virus infection in the past and this particular secondary complication.

      Don’t have the data to show but cardiac complications have been strongly associated with CMV. In organ transplantation, both acute and chronic rejection which is shown here, the scarring that builds up super infection and I’ll show data for that in just a second where you have CMV. The CMV weakens the immune system and then these other bacteria or fungal infections occur on top of that, super infection and that can then lead to lot of morbidity and mortality. And lastly, in cardiac transplantation, there is this atherosclerosis or chronic rejection of heart transplant which has been strongly associated with CMV.

      Now what about superinfections? So, these are data from a few years ago, looking at the risk of dying following ACT transplant based on whether the donor was CMV positive or the donor with CMV negative, you can see it’s a major causes of death or septicemia, aspergillus, infectious molds, bacterial infection, and is worse if the donor was CMV positive. So, donor CMV positive as on top of the risk of CMV as opposed to the donor being negative and these three virus are significant.

      So, it’s not the CMV that’s necessary killing the patient, that’s the rate that CMV here is the same, it is the superinfections leading to the death which is significant.

      Now similarly, in a liver transplantation here we look once again at the Ed Gain [ph] study and the placebo population of patients. There were 29 cases of CMV disease. Seven of those patients ended up dying for about a 28% incidence of death. If you did not have CMV disease, only 9 of those patients died or the incidence of death was 7%.

      So if you don’t give any prophylaxis in a liver transplant population the patients develop CMV disease. You have fourfold increased rate of dying, and most of those deaths are due to acute infectious complications, not specifically the virus but bacterial and fungal infections.

      Now what about other things that I worry about in my transplant population? Well that would be graft rejection. So this is kidney graft survival over a five-year time period here, and for same graft survival. You can see those patients who had a history of CMV disease in the white line has significantly worse graft survival over five years then those patients who did not have CMV disease. This is very impressive effect, much greater than some of our immunosuppressive drugs that we are seeing.

      Now, because of the problems with CMV, a series of options or therapies for seizures have been developed that try to prevent CMV from occurring in our transplant population. So what are these?

      One of them is to try to limit the viral exposure to your recipient. So if possible, use a CMV negative donor. So, you have CMV negative organ recipient and you can get a CMV negative kidney, the incidence of CMV is extremely low. The same with ACT. If your donor is negative and your recipient is negative, there is a flat line – there was no CMV.

      So, if possible, we try to use CMV negative donors, but that’s not always possible. In fact it’s frequently not possible with solo organ there is a such a shortage in organs that if you wait for this combination the patient may never get a transplant. In the ACT population where matching of HLA is so important you may not be able to transplantation if you want to “match your CMV and match for the our antigens.”

      Certainly you want to use a possible CMV negative blood product because CMV can’t be transplanted or transmitted with a CMV positive blood transfusion or platelet transfusion. And lastly, you can filter the leucocyte that is the blood, leave the red cells, get rid of the white cells because the white cells are the carrier for the CMV virus.

      Now, alternative to that if you can’t limit the exposure is to try to treat these virus either in a prophylaxis approach before they develop infection or after the virus is replicated. For that we will be using antiviral therapy. So the first two are sort of related approaches, and that’s called the prophylaxis approach.

      The universal prophylaxis means that every single transplantation gets antiviral prophylaxis. Now, most people don’t do that because the risk is not there for all patients and these drugs are very expensive. So most of us wouldn’t use if we did a prophylaxis would usually call selective approach.

      We look at the particular patient, we look at the donor and we say that this is a patient in a combination of a very high risk of CMV, let’s give antiviral prophylaxis. On the other hand maybe the donor is negative, the recipient is negative, we would say low risk for CMV we don’t want to waste the money and the exposure to the drug. So, that would be a selective approach.

      The alternative approach is the preemptive therapy and the way preemptive therapy works is you don’t give any antiviral prophylaxis and no antiviral therapy, and you monitor the patient for the development of viremia.

      Typically that’s done by preliminary of chain reactions, but it could be done by CMV antigenemia. If the patient starts to show evidence of viral replication, you see the virus in the blood, that indicates that’s the patient who is now at very high risk of progressing the CMV disease. We know that CMV disease is bad, so what you do would do that is once you see viremia, hopefully before the patient has developed symptomatic disease you would then give some sort of antiviral therapy to nip it in the bud, if you would.

      Another reason to use a preemptive therapy is that these agents here are quite often particularly in the ACT population they do impair recovery of the bone marrow. So, if you could avoid antitoxic agents during the recovery of the bone marrow that would be beneficial on that sort of preemptive approach more often using ACT. An alternative approach is to do nothing, monitor the patients, when the patient gets sick with CMV disease then you give some sort of active treatment.

      Now what are the drugs that are available for use? Well, these are the ones that are currently available. So slide on nebula virus immunoglobulin – CMV immunoglobulin or IVIG is approved for prophylaxis of kidney, lung, liver, pancreas and heart transplant. What differentiates CMV-IG from typical IVIG preparation is that the donors for this immunoglobulin have been screened to have high tittered anti-CMV antibodies. Otherwise it’s the same IVIG that would be used for other indications.

      Though acyclovir and its related drug acyclovir are effective, I will show some data on that for CMV prophylaxis, but are not indicated in the US for that. Again, acyclovir, both intravenous and oral formulation are approved for the treatment of CMV retinitis and prophylaxis of CMV disease and heart and bone marrow and though again acyclovir is relatively new comer on block which has been around now for about ten years is approved for treatment of CMV retinitis and prophylaxis for heart and kidney transplant but actually in the united states it’s not approved for prophylaxis of liver transplants.

      Now if you would like to go with the preemptive approach, which means you are not trying to give any antiviral therapy and so you see viremia then you are going to have to become comfortable with the fact that CMV viremia does predict CMV disease and higher the viral load, the higher the risk that the patient will go on to develop CMV disease. So, a preemptive strategy is effective – the idea is to try to nip it in the bud if you would, and so you monitor viremia.

      The success of that approach depends upon you being able to consistently monitor the patient for viral load. So as you do the transplant, have a cellular (inaudible) organ and then you have to monitor the patient by trying blood samples on a regular basis, acting and for getting the results back and acting upon those.

      It’s one thing if the patient is in the hospital, it’s another thing if the patient has gone home. There is no standardized accepted value at which threshold ones begin therapy, but you can use either Valacyclovir or Valogan or IV acyclovir prophylaxis, but there is no effect on CMV disease.

      Now what about some of the efficacy results? So this is what we see, for instance, with Valacyclovir. These are data from – for the period in New England Journal a few years back, ten years ago or so. Days after transplantation following kidney transplant, a percentage of patients who have CMV.

      In the placebo treated group here shown in yellow, once again, CMV disease occurring about 40 days post transplant in a kidney population, if you use Valacyclovir, very few cases of CMV disease of all the patients getting prophylaxis.

      When you stop the prophylaxis you see this better CMV occurring. I will talk about that in a little bit. That’s called late onset CMV, late onset because it is not happening here. But these two lines are parallel. So you do effectively prevent CMV by Valacyclovir prophylaxis, but not completely.

      Here’s a data from Valogam acyclovir. This is the Carlos pie data from in transplantation or AJT several years ago as well. Once again, time after transplant the incidence of CMV disease, the prophylaxis period of 100 days, no cases of CMV disease while the prophylaxis is being given. When the prophylaxis stops, here is this late onset CMV anywhere from 10% to 15% to 20% incidence of late onset CMV.

      Now if you can prevent CMV, it does have positive effects. So these are data from a heart transplant study in patients who have received CMV prophylaxis or not in the immediate post transplant period, now addressing the question of this post transplant cardiovascular disease. And in the heart transplant setting this post transplant cardiovascular disease or hardening of the arteries, if you would, lead to death of the patient.

      So this is a very good surrogate for a patient who is going to die. As you can see that those patients who did not receive CMV prophylaxis had significantly worse vis-à-vis cardiovascular coronary artery disease in those who had CMV prophylaxis. So, by providing CMV prophylaxis early post transplant the patients do better, they live longer. The same thing is seen in kidney transplants.

      So, this is three years after kidney transplant and this is now a kidney survival. Those patients who did not have CMV prophylaxis has significantly worse graft survival then those patients who did have CMV prophylaxis. So, CMV is a bad disease in either ACT or in solo organ transplant and leading to more survival.

      Now, we mentioned as superinfections These are interesting data that’s (inaudible) effective CMV on super infections. This is a med analysis by Hart General looking now at the incidence of the relative risk of various infections. So if you didn’t receive any anti-CMV therapy they peg this rate at one – arbitrary value of one. If you give anti-CMV prophylaxis with Ganciclovir, acyclovir or the like, you can see there is a 73% reduction in the incidence of herpes simplex and varicella zoster.

      So that shouldn’t be a surprise because these viruses are related to CMV and they are inhibited by Ganciclovir and acyclovir as well as CMV. But if you look here, bacterial infections and protozoa infection are basically nemesis’ are also significantly reduced by 35% and by 70%. Acyclovir, Ganciclovir have no activity on bacteria and no activity on TCP. But, by eliminating or preventing CMV, they therefore having this beneficial effect on these other secondary infections.

      Now we talk about (inaudible) organs a comparison of prophylaxis versus preemptive, both of them are effective at prevention of CMV organ disease. You can see there is a significant reduction in CMV organ disease whether you use prophylaxis or pre-emptive acute rejection is also reduced by both approaches. But, bacterial infections and death are only reduced by the prophylaxis approach because by allowing viral replication at least in solo organ you are still allowing that secondary effects that weaken a immune system.

      I mentioned late CMV, and that is a problem in transplant setting both for ACT and for solo organ. So what causes this late CMV? Well, first of all in CMV mismatch transplant, so particularly in solo organ if the donor is positive the recipient is negative, there was no chance for building up an immune reaction, those patients are more likely to develop late CMV disease after you stop prophylaxis.

      In a ACT population if you have this chronic (inaudible) as host disease where the immune system is constantly weakened by the graft of attacking host those people develop late CMV disease. If you have leucopenia or lymphocytopenia from immunosuppressive drugs, potent immune suppression, those are factors that lead to late CMV.

      But the most important factor is the lack of a specific immune response because the antiviral agents that we use are viral static, they are not viral cyto. So once you stop those antiviral therapies, the immune system unless it’s strong enough to take care of the virus, the virus will replicate. So, you really need to work on improving the immune system.

      And lastly drug resistance can lead to late onset CMV, but that’s pretty uncommon in our classified population. Now here are some data that was recently used to give Valganciclovir a new label for extended prophylaxis, and remember the original was 100 days of prophylaxis that’s shown here. These are the days after the study was started and the incidence of CMV.

      So, during the initial period time, when the patients receive in a 100 days of prophylaxis, no cases of CMV, you stop CMV prophylaxis, late onset CMV appears. Now you can increase the duration of prophylaxis now from 100 days to 200 days, again no CMV essentially during this period of time, but once you stop the CMV prophylaxis, CMV starts to appear.

      So this is late, late CMV. So even though you can extend the prophylaxis, you are not completely eliminating the virus because, remember it’s the immune system that ultimately controls the virus. So, what’s the problem with our current anti-CMV medications? Why should Vical or any other company be looking for additional approaches?

      Well of the current medications, the absorption is generally poor with Valacyclovir – talking about taking several grams of drug a day you need a lot of pills in order to do this. You can have breakthrough CMV ever after extended prophylaxis. There is a concern for viral resistance through anti-CMV therapy. There are poor for treatment at least in some of the cases. The drugs are very expensive and they do have a fair amount of toxicity associated with them.

      So, how can you prevent CMV? Well, along prophylaxis we showed – perfect, you can do monitoring. So once you stop the prophylaxis you can monitor the patient’s development of viremia. If you see viremia you can give even more antiviral therapy. Immunologic monitoring, such as the ability of the immune system to respond to the virus has been suggested as a possible way of monitoring them.

      Adoptive immune transfers such as additional intravenous hemaloglobulin or specific CMV T-lymphocytes have been talked about. But, on the cutting edge here, the thing we are looking at, we have been looking at it for a while is can we induce the immune system by a vaccine because if we can boost the immune system then that would eventually carry us through, once the antiviral therapy is stopped.

      So, in conclusion then, CMV disease shortens survival after transplant both for HCT and solid organ. Prophylaxis or preemptive antiviral therapy can prevent some of these notorious complications, preemptive therapy is still the standard of care in HCT particularly because of the concern for leucopenia and solid organ is sort of a pops up longer antiviral therapy may be advantageous in the solid organ transplantation, but we do need new approaches particularly focusing on leveraging the immune system. And with that, Rich.

      Rich Kenney

      Thank you, Dr. Pescowitz. That was a great review of CMV and the transplants setting, we said this little bit here. As you have seen antiviral therapy has dramatically improved outcomes in ACT but there is still a significant unmet need for better control of CMV. TransVax is a therapeutic vaccine is designed for transplantation from re-activation of CMV during the first year after the procedure when the most profoundly immuno-suppressed.

      Today, I am going to very briefly cover just to tide things up, the rationale for a vaccine approach, the results of our recently completed Phase II study and our plans for continued development. ACT has matured substantially in the past 20 years and is used in most types of leukemia and lymphoma after chemotherapy failure or in patients during their first remission.

      You and I have pretty healthy immune system that keeps CMV in check. If we are infected, a very large proportion of the immune cells in our blood, maybe up to 5% are actually directed against CMV, we have a very active immune response all the time against CMV.

      Transplantations, after they give the chemotherapy very rapidly – the chemotherapy kills the tumor cells will become profoundly immunosuppressed within a few days of that. CMV positive recipients therefore are at risk for recurrence for three reasons. First the dark cells are functioning inactive just after transplant. It takes time for them to differentiate perform and active immune response. Secondly, the patients can get continued immunosuppressive therapy in the month after the transplant (inaudible) prior to the CMV.

      Finally, even though CMV infection can usually be controlled with antiviral drugs reactivation have indirect effects, the transplant which is going to be risked from multiple recurrences. Thus the vaccine needs to be effective both early in the first three months after transplant as well as late so their immune surveillance can catch up to prevent the CMV disease.

      The four basic assumptions that we’ve used in developing this vaccine did well, that was in the literature. We know the reactivation is a significant problem soon after transplant in about 60% of the patients. Most patients are treated for CMV preemptively, that is reports check regularly for CMV and then there are only three if the test becomes positive.

      Treatments dramatically reduce the incidence of disease but it still occurs in about 5% and presents the unmet need. DNA vaccine is safe in this setting and can provide both T and B-cells stimulation. Improved immunity should reduce the number of reactivation episodes, so lately onset and reduce the duration of Viremia.

      And finally this has clinical implications since the decreased exposure of viremia as Dr. Pescowitz said, should lower the risk of toxicity from antiviral therapy and helps to control the CMV disease.

      The Vical product is composed of two plasmas that encodes CMV antigens, GV as a surface protein that induces antibodies that can neutralize the virus. pp65 as a segment protein is important for cellular immunity, and important and protection from occurrence. The prophylaxomer as an excipient, it enhances antigen production without causing inflammation.

      Overall, the TransVAX formulation is very easily used in outpatient setting. We have had actually made great progress in the studies in phase I and II in addressing safety and immunogenicity and we met key end points for just good path as clinical targets for phase III.

      Very briefly, the transplant concept is very straightforward. The recipient’s bone marrow is conditioned for several days before the transplant with a strong chemotherapy that serves to ablaze the tumor cells. Cells are then taken from a match related or unrelated donor, purified and then transferred to the recipient intravenously. We give the first vaccination before the material ablation to put the plasmas in the appropriate states to start the protein production.

      As a transplanted donor cells mature, repeated vaccination in the months after the transplant provides continued simulation that can boost the immune response.

      The phase II trials that we did was designed to define the best end points for phase III. We enrolled 80 adult subjects with leukemia or lymphoma, but that was scheduled for transplant and were previously infected with CMV.

      So the risks were randomized 1:1 for vaccines versus placebo, before transplant and we use the one, three and six months, after transplant in the phase II study to provide optimal immune simulation. Then end points in the phase II study includes a safety and immunogenicity as well as several critical efficacies end points that should antiviral therapy and viral load.

      This is the immune response that transacts vaccine elucidated very good T-cell immune response is for pp65 throughout the year after vaccination. Each dose is indicated by the arrows bottom, vaccine groups in green and the placebo groups in red. Immunogenicity was very strong, very early in the transplant period which is good even while the immune – the subjects were very immunosuppressed and they remain strong after the last dose up to a year.

      The difference between the groups was highly significant. This indicates that the DNA vaccination was active despite immune suppression and that long-term cellular immunity was being induced both early after transplants and in the late phase.

      This table summarize that the efficacy endpoints from the trial that were measured during the follow-up period, as you can see in the percent change column on the right, it crosses all the endpoints, the vaccine consistently cause a change in the right direction.

      That is the vaccine group had fewer events in the placebo group, most significant planning during the top three rows, the occurrence of CMV reactivation, the time of the reactivation and the presence of multiple events.

      These are the most important ways to look at the viral load. I’ll show a couple of these findings graphically in the following slides. This is the Kaplan-Meier curve it shows the percentage of subjects in each group who are protected from viremia over the year follow-up. You can see immediately that the vaccine is doing something very good in this population; only 32% of the vaccines develop viremia in the year after transplant, so they didn’t even hit 50% line, if we can make this work.

      Whereas half the placebo group developed viremia within the first 100 days, 62% of the placebo group eventually develop viremia which is red line with historical rate of about 60%. The significance was very statistically significant, the statistical difference was 0.03 which suggest this is the right type of market to take into Phase III.

      This is the last data slide and it’s a prevalence graph, it’s actually very simple count of a number subjects who develop viremia each month in the vaccine and placebo group, the lines here was smooth to help show the trend. Vaccine group in blue is clearly having fewer viremic episodes compared to the placebo group in red and we get the P value of 0.036.

      The approach to an end point in Phase III needs to be readily measured and to take up the problem that multiply episodes into account since those are the subjects that are at the highest risk of clinical CMV disease. This Andersen-Gill statistic combined the of the event multiple episodes and inter-event correlations, and this provides and excellence statistical approach allows us to calculate the hazard ratios that we need to determine the group size in Phase III.

      So to summarize in Phase II we’ve shown the TransVax improves the cellular and the hemaro immune [ph] response TransVax significantly outperform placebo on viral load end points including the occurrence of viremia reoccurrence of multiple events and the time the CMV viremia. Antiviral treatment was approved in Phase II but the study was not powered to show statistical difference, this could continue to serve as the secondary end point along with other end point like hospital utilization and survival.

      DNA vaccination is safe and appropriate for the very sick immune suppressed [ph] transplant population. Success in these subjects makes us atomistic so we can impact CMV disease in new born by vaccinating potential others before pregnancy with CyMVectin vaccine.

      So finally we are using these insights prepare the strategy for Phase III by combining the lessons learned. We met with clinical experts earlier this year to develop robust end point for Phase III, to link the time to infection reduces the risk that are associated with antiviral therapy, limiting the number of episodes, reduces the risk for CMV disease, so these are the end points that we came up with.

      We had a statistical consultation with Tom Fleming and he is the one actually who lets us do this Andersen-Gill model which allows to combine all these concepts into a single end point for Phase III. We are currently initiating discussions with regulatory authorities in both U.S. and the EU, it should be finalize in the middle of next year.

      We are making preparations now that are needed to start the pivotal study in late 2011, and in addition, we may conduct the parallel study in SOT, in the solid organ transplant to expand the safety database and run the potential market for this novel therapeutic vaccine.

      So at this point, I want to turn the mic over to Vijay to share the Q&A session.
      2 Antworten
      Avatar
      schrieb am 29.04.11 20:14:23
      Beitrag Nr. 143 ()
      übrigens am 05.Mai gibt es wieder Neuigkeiten von Vical zum 1.Quartal und auch einen weiteren Ausblick für 2011... :)
      Avatar
      schrieb am 10.05.11 21:21:51
      Beitrag Nr. 144 ()
      Jahreshoch :) mal sehen ob die Party morgen weiter geht :cool:
      Avatar
      schrieb am 11.05.11 11:54:57
      Beitrag Nr. 145 ()
      Vical to Present at Bank of America/Merrill Lynch Health Care Conference

      LAS VEGAS, May 9, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that Vijay B. Samant, President and Chief Executive Officer, will provide an overview of the company's technologies, development programs, and outlook

      on Wednesday, May 11, at 3:00 p.m. PDT (6:00 p.m. EDT) at the Bank of America/Merrill Lynch Health Care Conference (Las Vegas, May 10 -- 12).

      A webcast of Mr. Samant's presentation will be available live and archived through the Events & Presentations page in the Investors section of the Vical website at www.vical.com.


      http://finance.yahoo.com/news/Vical-to-Present-at-Bank-of-pz…
      1 Antwort
      Avatar
      schrieb am 11.05.11 11:58:00
      Beitrag Nr. 146 ()
      Vical to Present at Noble Financial Capital Markets Conference


      Press Release Source: Vical Incorporated On Tuesday May 10, 2011, 6:30 am EDT

      HOLLYWOOD, Fla., May 10, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that Vijay B. Samant, President and Chief Executive Officer, will provide an overview of the company's technologies, development programs, and outlook

      on Monday, May 16, at 2:00 p.m. EDT at the Noble Financial Capital Markets' Seventh Annual Equity Conference (Hollywood, FL, May 16 -- 17).

      A video-webcast of Mr. Samant's presentation will be available live and archived through the Events & Presentations page in the Investors section of the Vical website at www.vical.com.

      http://finance.yahoo.com/news/Vical-to-Present-at-Noble-pz-3…
      Avatar
      schrieb am 11.05.11 12:07:08
      Beitrag Nr. 147 ()
      Antwort auf Beitrag Nr.: 41.431.913 von McNay am 29.04.11 20:11:00So und da ich vermutlich Alleinunterhalter bin.........


      Hey McNay,

      Alleinunterhalter vielleicht, aber irgendwie doch nicht ganz allein > ich bin nämlich auch seit 21.01.11 investiert und hoffe, dass VICL ihren Weg machen wird.

      Time will tell :cool:

      Grüße bernie55 ;)
      1 Antwort
      Avatar
      schrieb am 11.05.11 12:13:18
      Beitrag Nr. 148 ()
      Antwort auf Beitrag Nr.: 41.484.391 von bernie55 am 11.05.11 12:07:08:D......sorry, seit dem 08.02.11 dabei....:D
      Avatar
      schrieb am 11.05.11 16:51:51
      Beitrag Nr. 149 ()
      das ist soo gemein! Ich habe die Aktie über Monate gehalten, ständig ein wenig im Minus und war froh als ich mit kleinem Gewinn wieder rausging. Seitdem hat sie sich verdoppelt.
      Avatar
      schrieb am 11.05.11 17:15:23
      Beitrag Nr. 150 ()
      Hallo bernie55 und dottore,
      schön das etwas Leben mit dem Jahreshoch hier im Thread zurückgekehrt ist, auch wenn es heute erst mal ein Minus gibt, aber nach dem Anstieg der letzten Tage ist das verkraftbar. :)
      Avatar
      schrieb am 12.05.11 09:48:30
      Beitrag Nr. 151 ()
      Antwort auf Beitrag Nr.: 41.484.301 von bernie55 am 11.05.11 11:54:57Vical to Present at Bank of America/Merrill Lynch Health Care Conference




      Vical Incorporated
      5/11/2011; 3:00 PM (PT)



      http://www.veracast.com/webcasts/baml/healthcare2011/id15322…
      Avatar
      schrieb am 12.05.11 09:51:16
      Beitrag Nr. 152 ()
      US Military and Vical Continue DNA Vaccine Collaboration

      By Theresa Phillips, About.com Guide May 11, 2011


      Awhile ago I wrote a piece about Inovio Pharmaceuticals and their in situ electroporation platform for delivering DNA vaccines. CEO Dr. Joseph Kim, in an interview, said he believed they had found the answer to DNA vaccine delivery, and that gave his company the advantage over everyone else. Well, watch out Dr. Kim, because you're not the only one who thinks you've found the secret to optimal DNA vaccine expression within human cells.

      Vical Inc., situated in the biotech hub of San Diego, California, has a patented DNA delivery system that has caught the attention of the US military. Their poloxamer delivery system for plasmid delivery has been found to increase the production of antigens and result in higher antibody responses in animal studies, compared to other delivery systems they've tested. Poloxamers are synthetic macromolecules consisting of a central hydrophobic chain of polyoxypropylene flanked by two hydrophilic chains of polyoxyethylene. Under the right incubation conditions, Vical has found a way to form a nanoparticle from the polymer that has a hydrophobic surfactant anchored on the surface. They can then attach DNA to that surfactant coating, for delivery into cells. Vical is working with the US Naval Medical Research Centre and has funding from the Defense Threat Reduction Agency, to develop vaccines for influenza. They announced last February that their agreement had been extended into 2011. The company released promising Phase I trial results for their vaccine to treat H1N1 pandemic influenza, at the end of April and announced last week that they recieved an additional US patent for their DNA vaccine to treat Herpes Simplex Virus type 2 (HSV-2) infections.

      http://biotech.about.com/b/2011/05/11/us-military-and-vical-…
      Avatar
      schrieb am 13.05.11 08:46:16
      Beitrag Nr. 153 ()
      Apropo Langer Atem:

      vical nur noch -80% bei mir, vor kurzem noch -90%!
      Macht also 100% plus!

      Gruß polya
      1 Antwort
      Avatar
      schrieb am 13.05.11 10:23:54
      Beitrag Nr. 154 ()
      Antwort auf Beitrag Nr.: 41.496.117 von polya am 13.05.11 08:46:16ich weiß nicht, was mehr weh tut. 120 % entgangener Anstieg seit meinem Ausstieg nach Monatelangem NICHTS

      oder 80% in den Miesen sein. Klar ist das letztere schlimmer, aber gefühlt ist es wohl sehr ähnlich
      Avatar
      schrieb am 15.05.11 16:00:02
      Beitrag Nr. 155 ()
      ;)...und zur Erinnerung...;)

      Vical to Present at Noble Financial Capital Markets Conference


      HOLLYWOOD, Fla., May 10, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that Vijay B. Samant, President and Chief Executive Officer, will provide an overview of the company's technologies, development programs, and outlook on Monday, May 16, at 2:00 p.m. EDT at the Noble Financial Capital Markets' Seventh Annual Equity Conference (Hollywood, FL, May 16 -- 17).
      Avatar
      schrieb am 16.05.11 21:22:48
      Beitrag Nr. 156 ()
      Presentations by Vical and Collaborators at CMV/BetaHerpesvirus Workshop

      05/16/2011

      NUREMBERG, Germany, May 16, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that Vical is presenting on the company's TransVax™ therapeutic cytomegalovirus (CMV) vaccine, and its CMV research collaborators are presenting on new vaccine approaches for prevention of congenital CMV infection, both at the 13th International CMV/BetaHerpesvirus Workshop (Nuremberg, Germany – May 14-17).

      Richard T. Kenney, M.D., Vical's Vice President of Clinical Development, is presenting an overview of clinical data from a completed Phase 2 trial and an outlook on potential endpoints for a planned Phase 3 trial of the company's TransVax™ therapeutic cytomegalovirus (CMV) vaccine for transplant recipients. Leading pediatric infectious disease researchers Stuart P. Adler, M.D., and Michael A. McVoy, Ph.D., of Virginia Commonwealth University (VCU), who are collaborating with Vical under a previously disclosed grant, are presenting an encouraging update on their initial results on novel CMV vaccine approaches for women of childbearing age.

      About TransVax™

      TransVax™ is a bivalent DNA vaccine containing plasmids (closed loops of DNA) encoding CMV pp65 and gB antigens for induction of both cellular and humoral immune responses. TransVax™ is formulated with a proprietary poloxamer-based delivery system. TransVax™ has received orphan drug designation in the United States for HCT and solid organ transplant patients.

      About CMV

      CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. While a healthy immune system typically protects an infected person against CMV disease, it rarely succeeds in eliminating the infection, and those whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death. Those at greatest risk include transplant patients and infants born to mothers who first become infected during pregnancy. Vical is pursuing two different vaccine approaches for these distinct market segments.
      Avatar
      schrieb am 19.05.11 07:56:11
      Beitrag Nr. 157 ()
      Auszüge aus:

      Vical, Exelixis Surge as Cancer Meeting Nears
      By Brett Chase May 17, 2011 2:30 pm

      Biotech company Vical’s (VICL) stock has more than doubled this year, Oncothyreon’s (ONTY) shares jumped almost 75% and Exelixis (EXEL) has risen by more than a third.

      All of the companies are developing experimental cancer treatments, and some investors are betting that the small-cap firms will release promising study data at the upcoming American Society of Clinical Oncology conference in Chicago next month. Investors will get a sneak preview of scores of scientific papers on drug research Wednesday evening when the cancer group, known as ASCO, will make much of the research available online. (Click here.)

      A number of companies presenting research at the conference, which includes the vast majority of biotech firms studying cancer therapies, will see their stocks move based on the data. As noted, some of these companies already are seeing their shares rise.

      Wednesday’s data dump and results of the actual presentations at the ASCO meeting June 3-7 can cause small company stocks to more than double. The conference is the biggest and most prestigious scientific meeting for cancer research in the country, drawing about 30,000 people.

      Michael Becker, a biotech industry consultant, calls the stock movements the ASCO effect, a term he coined a decade ago. Previously, only ASCO members were privy to the scientific papers, known as abstracts, before the research was presented at the conference. That allowed some --but not all-- investors to trade on the information prior to the research presentations. In recent years, ASCO reversed its policy and makes the abstracts available to anyone through the organization’s website.

      It’s tricky when companies such as Vical have such big stock run-ups prior to the abstracts even being released. So, it’s possible some stocks will surge before the conference only to drop later even if study data is positive. The conference presentations will update information on the companies’ studies, which can be significant given the pace of drug discovery.

      “It will be up to investors as to which (companies) still have some gas in the tank to reach higher price levels,” says Becker, senior partner at MD Becker Partners.

      There are around 300 publicly traded biotech companies and more than half are researching cancer treatments. Becker estimates more than 100 of these public biotech companies will present data. In all, there will be more than 4,000 abstracts.

      Investors should be bone up on current research themes. Cancer vaccines, for instance, still make up a fraction of the oncology drugs being developed, but Dendreon’s (DNDN) prostate cancer vaccine has highlighted the benefits of immunotherapy to treat cancer. (Also read Dendreon Presents Additional Provenge Safety Data.)

      Vical is conducting late-stage human studies for Allovectin-7, a vaccine to treat skin cancer patients. There’s a lot of focus on skin cancer research and the area is getting even more attention from investors since Bristol-Myers Squibb (BMY) won approval to sell the melanoma immunotherapy Yervoy this year. Bristol-Myers will present new Yervoy data at ASCO, which will spur more discussion about the treatment and the disease..


      Overall, ASCO presentations will include scores of potential first-line and second-line treatments for cancer, new types of chemotherapy and screening products. Those first-line treatments tend to attract a lot of investor interest.

      http://www.minyanville.com/businessmarkets/articles/asco-can…
      Avatar
      schrieb am 19.05.11 08:01:01
      Beitrag Nr. 158 ()
      Auszüge aus:

      5 Biotech ASCO Abstracts to Watch

      By Brian Orelli | More Articles
      May 18, 2011 | Comments (0)

      The ASCO abstracts are coming!

      The biotech investors' Christmas in May is once again upon us. Throw on your pajamas and head here today at 6 p.m. Eastern, where investors and researchers alike will be able to find the synopsis of what will be presented at the American Society of Clinical Oncology annual meeting next month.

      Until we get to unwrap the presents, here's a look at five companies that might have interesting data.


      ---------------------------------------------

      A long time coming
      We'll have to wait and see what Vical (Nasdaq: VICL ) has to offer at ASCO; its presentation title, "Association of response and survival in Allovectin melanoma trials," isn't all that descriptive. But investors shouldn't hold out hope for new data. The final readout for the phase 3 trial of Allovectin isn't expected until the second half of this year.

      Vical presented phase 2 data for Allovectin at ASCO 2000, some 11 years ago. If that isn't a sign about the slow nature of drug development, I don't know what is.

      http://www.fool.com/investing/high-growth/2011/05/18/5-biote…
      Avatar
      schrieb am 07.06.11 12:01:56
      Beitrag Nr. 159 ()
      Vical Presents Positive Correlation Between Response and Survival at ASCO for Completed Allovectin(R) Melanoma Trials

      HICAGO, June 6, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced results from new statistical analyses of data from three previously completed clinical trials of the company's Allovectin(R) immunotherapy in patients with metastatic melanoma, showing with strong positive correlation that responders lived significantly longer than nonresponders.
      In a Phase 2 study of high-dose (2 mg) Allovectin(R) in 127 chemo-refractory or chemo-intolerant patients with metastatic melanoma, the overall survival was

      65% at one year,
      43% at two years,
      and 32% at three years.

      the median overall survival was 18.8 months (95% CI: 14.8 -- 26.2 months). Survival among the 15 clinical responders ranged from 18 months to more than seven years (median survival not reached; 95% CI: 35.5 months -- not reached). The median overall survival for nonresponders in the Phase 2 study was 16.2 months (95% CI: 13.3 -- 21.2 months), which is notably longer than historical survival for other metastatic melanoma treatments, suggesting that these patients also may have derived clinical benefit from Allovectin(R).

      http://finance.yahoo.com/news/Vical-Presents-Positive-pz-280…
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      schrieb am 07.06.11 12:03:19
      Beitrag Nr. 160 ()
      Vical to Present at Jefferies Global Healthcare Conference

      NEW YORK, June 2, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that Vijay B. Samant, President and Chief Executive Officer, will provide an overview of the company's technologies, development programs, and outlook on Thursday, June 9, at 11:00 a.m. EDT at the Jefferies 2011 Global Healthcare Conference (New York, June 6 -- 9).

      A webcast of Mr. Samant's presentation will be available live and archived through the Events & Presentations page in the Investors section of the Vical website at www.vical.com.

      http://finance.yahoo.com/news/Vical-to-Present-at-Jefferies-…
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      schrieb am 23.06.11 16:39:11
      Beitrag Nr. 161 ()
      Careful Analysis Reveals Good Probability of Large Gains for Vical

      June 1, 2011 | about: VICL


      Vical (VICL) is a biotechnology company with a cancer drug (Allovectin-7 (or A-7)) nearing completion of its pivotal phase 3 clinical trial. Normally when I put together an investment thesis on a stock, I try to estimate a future share price based on projected earnings at a reasonable P/E multiple. For this write up, I will mostly defer to this Conaccord Genuity analyst report. If Vical is successful in getting A-7 approved, the analyst predicts U.S. launch and profitability in 2013, E.U. launch in 2014, and ~$1 billion in sales and $330 million of net income in 2018. Based on those numbers, and assuming a 25% chance of success for A-7, and a 12% discount rate, Conaccord Genuity has a price target of $8 for VICL. It currently trades just under $4.

      For the most part Conaccord’s analyst report looks about right to me. Where my opinion differs substantially is on the estimated 25% chance of success. I would say that 50% is a very conservative estimate of the likelihood of success. Based on that probability, the price target should be $16/share. And to be honest, my read of the information suggests that the odds are probably closer to 75%, which would put the price target at $24/share. That represents a 500% gain from current prices.

      That’s a very attractive potential opportunity, but we have to keep in mind that this is a bit of a lottery ticket. If Vical is unsuccessful with A-7, expect drastic losses on this investment.

      So let’s look at the data that makes me so confident that Vical will be successful with A-7. The phase 3 trial for Allovectin-7 is in metastatic melanoma, a late-stage, aggressive form of skin cancer for which the best therapies give a median survival time of only 6-9 months. Vical has already completed a phase 2 trial of A-7 in metastatic melanoma, so we can look at the results of that trial to see what we might expect from the phase 3 trial.

      I’ll consider the Allovectin-7 safety data first, since that data is simple and compelling. Cancer drugs generally have nasty side effects. In a trial of the standard metastatic melanoma drug DTIC (dacarbazine), 22% of patients had severe (grade 3 or 4) side effects. For the recently approved drug Yervoy (Ipilimumab, from Bristol Myers Squibb (BMY)) grade 3 and 4 side effects were reported in 23% of patients (including a number of drug-related deaths). In the phase 2 trial of A-7, there were no reports of grade 3 or 4 events. Zero. That will be a major advantage for Vical/A-7 when it comes to competing with other drugs on the market.

      Now let’s consider the phase 2 efficacy results. Here is a slide from a Vical slide set that shows the above-mentioned safety data along with some efficacy comparisons.



      DTIC is used in the control arm of the ongoing phase 3 trial, so that is the most important comparison. For now, I will focus strictly on the standard efficacy measures: response rate and median survival. I’ll get to the durable response and duration of response later. Response rate is the percent of patients with significant tumor shrinkage (50+%) at any point in the treatment. This is the primary endpoint for the phase 3 trial, and A-7 showed significantly better results in phase 2 compared to DTIC in this historical study. Median survival is the secondary endpoint of the phase 3 trial, and A-7 shows well over double the survival time of DTIC (18.8 months vs. 7.8 months). From another slide in the same presentation DTIC is shown to have a typical 1 year survival rate of 25% compared to 65% for A-7 in the phase 2 trial. And I’ve found another reference that shows typical 18 month survival rates to be roughly 11%, which is also substantially lower than the ~50% rate for A-7.

      So just based on the phase 2 results, I would have estimated a greater than 25% chance of success for A-7. Now let me describe some changes that were made to the phase 3 protocol that I believe substantially increase its chances of success. First, in the phase 2 trial patients typically didn’t respond to A-7 until roughly 16 weeks of treatment. A-7 is an immunotherapy (it causes the cancer cells to be targeted by the immune system), and it seems that this mechanism takes longer to have an effect than chemotherapy. The phase 2 protocol required that patients stop treatment if there was any tumor progression. Because of this requirement, 62% of the A-7 patients had the treatment stopped with less than eight weeks of treatment, before it had much chance to have an effect. The phase 3 protocol stipulates that all patients will receive at least 16 weeks of treatment with A-7. This should significantly increase the response rates. Very optimistically, with 2-3 times as many patients receiving a full course of treatment (100% in phase 3 compared to 38% in phase 2), you might expect response rates to be 2-3 times higher. More conservatively, it clearly increases the likelihood of improving on the approval-worthy (superior to Yervoy) response rate of the phase 2 trial (11.8%).

      The second change to the phase 3 protocol is the timing of the response assessment. The phase 2 trial counted responses that occurred at any time during treatment. Chemotherapy for metastatic melanoma exerts its effect very quickly, in the first few weeks of treatment (if it has an effect at all), but patients generally relapse in the subsequent few months. By contrast, A-7 responses were slower but much longer-lived. The phase 3 trial only counts responses that are still in effect six months after the beginning of treatment. This is what is labeled as “durable response” in the table above. You can see that by this measure, DTIC’s response rate drops from 7.5% to 3.6%, while A-7 still has a 11.8% response rate at six months. So while A-7’s response rate was 57% higher (11.8 vs. 7.5) than DTIC according to the standards of the phase 2 trial, they are 228% higher (11.8 vs. 3.6) than DTIC by the phase 3 standards. This change also seems to move the odds very much in Vical’s favor in phase 3.

      The third beneficial change in the phase 3 protocol is a restriction on the patients enrolled. In the phase 2 trial, roughly 40% of patients had failed chemotherapy, and only one of those patients responded to A-7. Of the 60% who were chemotherapy naive, 14 patients responded. So it seems that A-7 is more effective on chemotherapy naive patients, and the phase 3 trial excludes patients who have been previously treated with chemotherapy. This change should also increase the response and survival rates.

      Having committed these arguments to writing, I feel like even my 75% probability of success might be conservative. But clinical trials do have a way of throwing curve balls, so I’ll stick with my 75% number. As I stated above, that implies that Vical’s stock is wildly underpriced (under $4/share compared to a price target of $24) based on its high probability of success with a high-value drug (though with a 25% chance of major losses).

      Just a few more details to wrap this story up. Vical expects to have the data from the phase 3 trial by the end of this year, but it could come as late as February 2012. At that point, we’ll no longer be dealing with probabilities. At that point, the trial will have failed (price target: $1?, 75% loss) or succeeded (price target: ~$32, 700% gain). If it is successful, the mechanism of A-7 is not specific to melanoma. If it works in this trial, it should hypothetically be effective against any solid tumor. Also, there is more to Vical than Allovectin-7. It has an influenza vaccine in phase 1 trials, a cytomegalovirus vaccine almost ready for phase 3 trials, and a critical limb ischemia treatment that has already shown impressive phase 3 results (unfortunately, it will only get single-digit royalties on this product).

      So if A-7 works out for Vical, the company has some great opportunities to reinvest profits for even more growth.

      Finally, there’s a nice video presentation with slides available here, where you can see Vical’s CEO present the case for the company and Allovectin-7.

      Disclosure: I am long VICL.
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      schrieb am 28.06.11 13:14:55
      Beitrag Nr. 162 ()
      Vical Provides Allovectin(R) and Herpes Simplex Vaccine Updates at BIO International Convention

      WASHINGTON, June 28, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) announced today that the company is presenting updates on its Phase 3 Allovectin(R) immunotherapeutic for metastatic melanoma and its preclinical herpes simplex type 2 (HSV-2) vaccine at the BIO International Convention (Washington, DC -- June 27-30).

      Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development is presenting both updates in breakout sessions of the Innovations in Vaccines Track on Tuesday, June 28.
      The HSV-2 vaccine presentation is included in the "Therapeutic and Prophylactic Approaches for the Treatment of HSV-2 Infection" session scheduled for 10:00 a.m. EDT and the Allovectin(R) presentation is included in the "Therapeutic Cancer DNA Vaccines: Advances in Technologies, Advances in Clinical Success" session scheduled for 2:00 p.m. EDT.




      Allovectin(R) Update


      Allovectin(R) is a systemic immunotherapeutic with a unique mechanism of action that may be complementary to currently approved treatments. Allovectin(R) is delivered into a single tumor lesion, but elicits a T-cell immune response directed against similar tumor lesions throughout the body. Vical is currently conducting animal studies to evaluate the potential synergy of Allovectin(R) with an anti-CTLA-4 monoclonal antibody, which works by expanding the number of active T cells.

      Earlier this month at the Annual Meeting of the American Society of Clinical Oncology (ASCO), Vical presented statistical analyses of data from three previously completed clinical trials of Allovectin(R) in patients with metastatic melanoma, showing with strong positive correlation that responders lived significantly longer than nonresponders. In Vical's ongoing Phase 3 trial of Allovectin(R), the primary endpoint is objective response rate at 24 weeks or more after randomization, and overall survival is a secondary endpoint.

      The Phase 3 trial is evaluating Allovectin(R)compared with standard chemotherapy as a first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. Vical completed enrollment in February 2010 of 390 chemo-naive patients randomized on a 2:1 basis for treatment with Allovectin(R) or chemotherapy (physician's choice of either dacarbazine or temozolomide).

      Allovectin(R) has demonstrated an excellent safety profile in multiple clinical trials. In the high-dose Phase 2 trial, there were no grade 3 or grade 4 drug-related adverse events. Safety has been a hallmark of Allovectin(R) treatment, and side effects typically have been local and not significant.

      The mechanism of action for Allovectin(R) is applicable to solid tumors other than melanoma, and Vical has conducted early-stage clinical trials of Allovectin(R) in patients with breast, prostate, colorectal or kidney cancer, chronic lymphocytic leukemia, or squamous cell cancer of the head and neck. AnGes MG, Inc., has licensed rights to commercialize Allovectin(R) in specified Asian countries, and is primarily interested in developing Allovectin(R) as a treatment for head and neck cancer, which presents a significant unmet medical need in Asia. Vical estimates that the worldwide market for Allovectin(R) as a treatment for metastatic melanoma could exceed $500 million annually, and applications for other types of cancer could further expand its total use.

      HSV-2 Vaccine Update

      Vical is collaborating with the University of Washington School of Medicine and the Sealy Center for Vaccine Development at the University of Texas Medical Branch under a previously disclosed grant on the preclinical development of a HSV-2 vaccine formulated with Vical's Vaxfectin(R) adjuvant. The initial focus will be for people already infected with HSV-2, with the goal of reducing or eliminating periodic viral flare-ups as well as viral shedding and transmission.

      Data being presented today from repeat studies confirmed that the company's Vaxfectin(R) adjuvant significantly improved vaccine effectiveness (p<0.05). Vical's therapeutic vaccine significantly reduced the recurrence of HSV-2 lesions in guinea pigs with latent infection (p<0.05). A related prophylactic vaccine protected mice against lethal HSV-2 challenge (p<0.0001), provided sterilizing immunity (p<0.05) and inhibited post-challenge viral shedding at the primary infection site (p<0.05) and viral load at the latent infection site (p=0.007).

      HSV-2 is a sexually transmitted virus which is the leading cause of genital herpes.Approximately one out of every six individuals in the United States and an estimated one out of every four worldwide is infected by HSV-2 before age 50. HSV-2 infections are persistent and result in periodic virus shedding. HSV-2 infection also significantly increases the risk of acquiring HIV-1. In the United States, at least 40 million people are infected with HSV-2, and approximately 1.6 million people are newly infected each year, with approximately 500,000 of those suffering from disease symptoms. Even higher infection rates are evident in developing countries, with further complications in people also infected with HIV.

      There is currently no approved vaccine for HSV-2. Although antiviral regimens have become a standard of care, their inconvenience, cumulative cost over the years and potential for drug resistance highlight the need for safe, new approaches to reducing HSV-2 lesions, shedding, and transmission. Estimated direct costs of treating HSV-2 in the United States alone are close to $1 billion annually, primarily for drugs and outpatient medical care, plus additional indirect costs of more than $200 million.

      http://finance.yahoo.com/news/Vical-Provides-AllovectinR-pz-…
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      schrieb am 14.07.11 16:54:42
      Beitrag Nr. 163 ()
      Vical Announces Scientific Advances for Multiple Programs at DNA Vaccines 2011 Conference

      SAN DIEGO, July 14, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) announced today a summary of the company's scientific presentations at the DNA Vaccines 2011 conference, (San Diego -- July 12-14).

      TransVax(TM)

      A presentation by Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development, "Phase 2 Clinical Trial Results of a Therapeutic DNA Vaccine, TransVax(TM), for Control of Cytomegalovirus in Hematopoietic Cell Transplant Recipients," features the most advanced clinical data presented at the conference.

      Key efficacy, immunogenicity and safety results from the completed Phase 2 trial establish Vical's TransVax(TM) cytomegalovirus (CMV) vaccine as the first to provide evidence of protection in immunocompromised hematopoietic cell transplant (HCT) recipients. Through 12 months post-transplant, statistically significant improvements were achieved compared to the placebo group for all key viral reactivation endpoints: the occurrence of CMV viremia, the median time to initial viremia, the number of CMV viremia episodes, the duration of viremia, and the prevalence of CMV viremia episodes over the trial period. The presentation further outlines preparations for the planned Phase 3 registration trial of TransVax(TM).

      Dr. Rolland is also a Panelist in a Plenary Roundtable, "Development and Commercialization of Novel Vaccines," and Chair of the Immune Mechanisms & Vaccine Session.

      Herpes Simplex Vaccine

      A presentation by Sean M. Sullivan, Ph.D., Vical's Executive Director of Pharmaceutical Sciences, "Development of Vaxfectin(R)-formulated HSV-2 Plasmid DNA Vaccines for Prophylactic and Therapeutic Applications," highlights the latest preclinical data from the company's herpes simplex virus type 2 (HSV-2) vaccine development program. The company previously reported encouraging data showing that its Vaxfectin(R)-formulated monovalent prophylactic vaccine (encoding HSV-2 glycoprotein D, or gD) protected mice against challenge with 50 times a lethal dose (LD50) of HSV-2, provided sterilizing immunity and inhibited viral counts at both primary and latent infection sites. The Vaxfectin(R) adjuvant significantly improved vaccine effectiveness. A Vaxfectin(R)-formulated trivalent therapeutic version of the vaccine (encoding gD plus the HSV-2 tegument proteins UL46 and UL47) significantly reduced (p<0.05) the recurrence of lesions in guinea pigs with latent infection as well as viral shedding. The company subsequently completed repeat studies confirming these results, which are among the best ever seen with a herpes vaccine in such a therapeutic model. New data presented at the conference shows that a 0.1 ug dose of the prophylactic vaccine provided 100% protection of mice against challenge with 50 times a lethal dose (LD50), and a 100 ug dose of the prophylactic vaccine provided 100% protection of mice against challenge with 500 times a lethal dose (LD50). The 100 ug dose of the prophylactic vaccine also significantly reduced viral shedding at the primary infection site (p<0.001) and inhibited viral counts at the latent infection site (p<=0.05). Both the monovalent and trivalent vaccines completely eliminated primary disease and recurrent disease in a prophylactic guinea pig model.

      Dr. Sullivan is also presenting key data from the HSV-2 program in a poster at the conference.

      CyMVectin(TM)


      A poster presented by Jukka A. Hartikka, Ph.D., Vical's Associate Director of Vaccinology, "Preclinical Evaluation of the Immunogenicity of Plasmid DNA-based Prophylactic Vaccines for Human Cytomegalovirus," detailed the preclinical results supporting clinical development of the company's CyMVectin(TM) prophylactic CMV vaccine. By prophylactic vaccination of women of childbearing age CyMVectin(TM) is designed to prevent CMV infection and consequently maternal-fetal transmission of CMV, a leading cause of birth defects. Results from a mouse study demonstrated that immunization with a Vaxfectin(R)-formulated bivalent CMV vaccine, expressing gB and pp65, resulted in durable cellular immune responses. Optimizing the dosing regimen greatly increased the number of CMV-specific T cells. Data obtained in mice and rabbits demonstrated that DNA vaccines formulated with the company's Vaxfectin(R) adjuvant provided superior immunogenicity compared to other formulations. The Vaxfectin(R)-formulated DNA vaccines administered without electroporation provided equivalent or better immunogenicity than unformulated DNA vaccines followed by electroporation with either constant-voltage or constant-current devices. Needle-free delivery did not provide a significant advantage over conventional needle and syringe delivery. Accordingly, the company has formulated its CyMVectin(TM) vaccine with Vaxfectin(R) and designed its Phase 1 trial protocol with conventional needle and syringe delivery. The U.S. Food and Drug Administration has allowed the company's Investigational New Drug application (IND), clearing the path for the company to advance to initial human clinical testing of CyMVectin(TM).

      RapidResponse(TM) Platform

      A poster presented by John Doukas, Ph.D., Vical's Senior Director of Preclinical Safety and Efficacy, "Advances in the Development of Linear Expression Cassette-based Pandemic Influenza A Vaccines," provides results from the company's RapidResponse(TM) DNA vaccine cell-free manufacturing process. The RapidResponse(TM) platform is designed to allow extremely rapid and large-scale production of DNA vaccines with low capital requirements. It is ideally suited to enable an immediate response against emerging diseases affecting large populations. Development of the RapidResponse(TM) platform was funded by a grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

      In a lethal challenge study with a pandemic influenza virus, ferrets were vaccinated with Vaxfectin(R)-adjuvanted, RapidResponse(TM)-produced vaccine. A dose of 330 μg provided complete protection against viral challenge, while a 10-fold lower dose still provided a high level of protection (83% survival rate compared to 0% in controls). Both doses reduced peak nasal wash viral titers by >40%, and stabilized body weights and temperatures. GLP-compliant repeat-dose toxicology, biodistribution, and genomic integration studies required to position such vaccines for clinical trials were conducted in rabbits and confirmed that a vaccine produced by the RapidResponse(TM) system was well-tolerated.

      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

      This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical's TransVax(TM) vaccine, HSV-2 vaccine, CyMVectin(TM) vaccine and RapidResponse(TM) platform, as well as the company's focus, collaborative partners, and product candidates. Risks and uncertainties include whether Vical or others will continue development of TransVax(TM), the HSV-2 vaccine, CyMVectin(TM), the RapidResponse(TM) platform, or other product candidates; whether any product candidates will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

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      schrieb am 15.07.11 08:26:39
      Beitrag Nr. 164 ()
      :) Vical, Astellas ink licensing deal on vaccine :)


      On Thursday July 14, 2011, 8:58 pm EDT

      SAN DIEGO (AP) -- Drug developer Vical Inc. said Thursday that it has signed a global licensing agreement with Astellas Pharma Inc. to develop and commercialize a drug aimed at preventing a potentially fatal virus in stem-cell transplant patients.

      The companies expect to begin a multinational, Phase 3 registration trial of the cytomegalovirus vaccine, dubbed TransVax, in certain stem-cell transplant recipients. They also plan a Phase 2 trial in solid organ transplant recipients in the first half of next year.

      Cytomegalovirus can cause respiratory illness and is suppressed by the immune system in most people. But it can cause transplant rejection if it flares up when a transplant recipient's immune system is suppressed during recovery.

      The companies' pact calls for Astellas to cover all costs to develop the drug further and commercialize it.

      Vical has an option to co-promote TransVax in the U.S., and will assist Astellas in manufacturing the drug, as well as in handling regulatory and certain development functions.

      In return, Astellas has agreed to reimburse all of Vical's future costs, including personnel and external expenses.

      Vical is scheduled to receive $35 million in payments, but could potentially receive up to $130 million in total upfront and milestone payments through commercial launch and double-digit royalties on net sales, the company said.

      Vical shares gained 50 cents, or 11.6 percent, to $4.80 in aftermarket trading. The shares shed 18 cents, or 4 percent, during the regular session.

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      schrieb am 21.07.11 11:30:52
      Beitrag Nr. 165 ()
      Vical Gets Some Validation
      Jul 19, 2011 03:00 AM by Stephen D. Simpson, CFA

      Investors in small-cap vaccine biotech Vical (Nasdaq:VICL) received some good news late on Thursday, as the company announced a licensing deal with a major Japanese pharmaceutical company.
      While this is a solid deal that will bring some more cash into the business, the real question for investors these days is whether Vical's candidate for metastatic melanoma can ultimately obtain FDA approval and then stand with the likes of Bristol-Myers' (NYSE:BMY) Yervoy in the market.
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      schrieb am 21.07.11 16:06:44
      Beitrag Nr. 166 ()
      Vical Reports Successful Nonclinical Results With Vaxfectin(R) Adjuvant
      globenewswire


      Press Release Source: Vical Incorporated On Thursday July 21, 2011, 6:30 am EDT

      SAN DIEGO, July 21, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) announced today the publication in the journal Vaccine1 of successful results from nonclinical testing of its Vaxfectin(R) adjuvant and Vaxfectin(R)-formulated plasmid DNA (pDNA) vaccines against pandemic influenza prior to their first use in human clinical trials. The results pave the path for potential future human applications of Vaxfectin(R) as a universal adjuvant for additional pDNA vaccines, for conventional protein-based infectious disease vaccines, and for cancer vaccines.

      Vaxfectin(R) is a lipid-based adjuvant initially developed for use with DNA vaccines. Vaxfectin(R) has been shown in multiple animal models to significantly increase the antibody and T-cell immune responses to antigens expressed from DNA vaccines. Vaxfectin(R) has achieved similar effects with protein-based vaccines for infectious diseases and with tumor-associated antigen peptides for cancer applications. Phase 1 clinical trials of Vaxfectin(R)-formulated H5N1 and H1N1 pandemic influenza DNA vaccines extended the immunogenicity results to humans, and demonstrated favorable safety and tolerability. The current publication reviews the nonclinical results that supported the advancement of the Vaxfectin(R)-formulated DNA pandemic influenza vaccines into clinical development.
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      schrieb am 25.07.11 13:41:13
      Beitrag Nr. 167 ()
      Vical Announces Early Termination of Hart-Scott-Rodino Waiting Period for TransVax(TM) License Agreements With Astellas
      globenewswire


      Press Release Source: Vical Incorporated On Monday July 25, 2011, 6:30 am EDT

      SAN DIEGO, July 25, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 was terminated early on July 22, 2011, in connection with Vical's previously announced exclusive worldwide license agreements with Astellas Pharma Inc., (TOKYO:4503) for the development and commercialization of TransVax(TM), Vical's therapeutic vaccine designed to control cytomegalovirus (CMV) reactivation in transplant recipients. As a result, the agreements have become effective, triggering the initial upfront payment of $25 million from Astellas to Vical, which is expected within 30 days.

      As previously disclosed, Astellas will be responsible for further development and commercialization, including all costs. Vical has an option to co-promote TransVax(TM) in the United States. Vical will provide assistance to Astellas with TransVax(TM)-related manufacturing, regulatory and certain development activities, for which Astellas will reimburse all of Vical's future costs, including personnel and external expenses. The companies expect to begin a multinational Phase 3 registration trial of TransVax(TM) in hematopoietic stem cell transplant (HSCT) recipients as well as a Phase 2 trial in solid organ transplant (SOT) recipients in the first half of 2012. Vical will receive an additional $10 million upon finalization of the Phase 3 trial design. Vical potentially will receive up to $130 million in total upfront and milestone payments through commercial launch and double-digit royalties on net sales.

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      schrieb am 31.08.11 00:04:50
      Beitrag Nr. 168 ()
      Antwort auf Beitrag Nr.: 41.839.624 von bernie55 am 25.07.11 13:41:13Bin auch dabei. Hab sie für 2,32 Euro vor ca. 14 Tagen bekommen. Ich denke, die 3 Euro sind realistisch bis Ende September. Viel Glück allen Investierten;)
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      schrieb am 22.09.11 17:16:12
      Beitrag Nr. 169 ()
      Allovectin(R) Demonstrates Synergistic Efficacy With Anti-CTLA-4 Antibody in Melanoma Animal Model


      Symbol Price Change
      VICL 2.85 +0.42

      Press Release Source: Vical Incorporated On Thursday September 22, 2011, 6:30 am EDT

      BETHESDA, Md., Sept. 22, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) announced today encouraging animal data demonstrating a synergistic (more than additive) improvement in efficacy using a combination of the company's Allovectin(R) immunotherapy with an anti-CTLA-4 antibody

      Treatment with Allovectin(R) plus anti-CTLA-4 antibody provided a synergistic reduction of tumor growth compared with either treatment alone (both p<0.001).

      Synergy became evident about 12 days after treatment initiation, suggesting a likely two-step process in which Allovectin(R) first directs T cells to target the melanoma tumor and anti-CTLA-4 antibody then maximally activates these T cells.
      Treatment with Allovectin(R) plus anti-CTLA-4 antibody provided a positive trend in survival compared with either treatment alone.
      Allovectin(R) alone significantly reduced tumor growth and significantly increased survival time compared with anti-CTLA-4 antibody treatment alone and compared with no treatment (all p<0.001).

      "We expected a synergistic effect with this co-treatment, and were pleased that this study confirmed it," said Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development. "Allovectin(R) directs a potent and multifaceted systemic immune response against the target cancer cells, and anti-CTLA-4 antibodies drive the activation of additional T cells. Together, these complementary therapies can provide a powerful one-two punch."

      The study was conducted in a well-accepted melanoma mouse model using a standard mouse equivalent of human anti-CTLA-4 antibodies such as ipilimumab. Cohorts included untreated mice, mice treated with Allovectin(R) alone, mice treated with anti-CTLA-4 antibody alone, and mice treated with Allovectin(R) plus anti-CTLA-4 antibody. Dosing for Allovectin(R) was a single cycle of once per day for the first four days. Dosing for the anti-CTLA-4 antibody was once every three days for the duration of the study. The study tracked growth of implanted melanoma tumors and survival. Results were encouraging and support further evaluation of such combination treatment in human clinical trials.

      John Doukas, Ph.D., Vical's Senior Director of Pre-clinical Safety and Efficacy, presented the results, "Synergistic Anti-Tumor Efficacy Using Allovectin(R) and Anti-CTLA-4 Combination Immunotherapy in a Murine Melanoma Model," at the National Cancer Institute Conference on Cancer Immunology and Immunotherapy: Building on Success (Bethesda, MD -- September 22-23).

      About Allovectin(R)

      Allovectin(R) is a systemic immunotherapeutic with a unique mechanism of action that may be complementary to currently approved treatments. It is delivered into a single tumor lesion, but elicits an immune response directed against lesions throughout the body. Among patients with more than one lesion at baseline in a completed high-dose Phase 2 study, 57% of clinical responders and 17% of clinical nonresponders had tumor responses in noninjected lesions. Vical's ongoing Phase 3 trial is evaluating Allovectin(R) compared with standard chemotherapy as a first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. The primary endpoint is objective response rate at 24 weeks or more after randomization, and overall survival is a secondary endpoint. Vical completed enrollment in February 2010 of 390 chemo-naive patients randomized on a 2:1 basis for treatment with Allovectin(R) or chemotherapy (physician's choice of either dacarbazine or temozolomide). The company expects to complete treatment and follow-up for the primary endpoint in the Phase 3 trial by February 2012, with continued monitoring for the secondary endpoint up to the release of top-line data for both endpoints in the second quarter of 2012.

      Allovectin(R) has demonstrated an excellent safety profile in multiple clinical trials. In the high-dose Phase 2 trial, there were no grade 3 or grade 4 drug-related adverse events. Safety has been a hallmark of Allovectin(R) treatment, and side effects typically have been local and not significant.

      http://finance.yahoo.com/news/Allovectin-R-Demonstrates-pz-3…
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      schrieb am 19.10.11 12:06:47
      Beitrag Nr. 170 ()
      Vical to Present at NewsMakers Conference

      SAN DIEGO, Oct. 17, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that the company's President and Chief Executive Officer, Vijay B. Samant, will provide an overview of the company's technologies, development programs, and strategic partnerships at the BioCentury/Thomson Reuters NewsMakers in the Biotech Industry Conference (New York, October 21; presentation at 11:30 a.m. ET).

      A webcast of Mr. Samant's presentation will be available live and archived through the Events page in the Investors section of the Vical website at www.vical.com.
      http://finance.yahoo.com/news/Vical-Present-NewsMakers-pz-83…" target="_blank" rel="nofollow ugc noopener">
      http://finance.yahoo.com/news/Vical-Present-NewsMakers-pz-83…
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      schrieb am 25.10.11 14:04:37
      Beitrag Nr. 171 ()
      Vical Announces News Release and Conference Call Schedule for Third Quarter 2011 Financial Results

      Press Release Source: Vical Incorporated On Tuesday October 25, 2011, 6:30 am EDT

      SAN DIEGO, Oct. 25, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that the company will report financial results for the three months and nine months ended September 30, 2011, before the opening of trading on Tuesday, November 1, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Tuesday, November 1.

      The call is open on a listen-only basis to any interested parties. The company will provide details on independent and partnered development programs in the conference call and webcast.

      Conference Call

      To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 325-2383 (preferred), or (888) 515-2880 (toll-free), and reference confirmation code 1312814. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 1312814. The call also will be available live and archived through the events page at www.vical.com.

      Invited analysts and institutional investors may ask questions during the conference call. Others may submit questions before the call by e-mail addressed to ir@vical.com or by fax to (858) 646-1150. Submitted questions will be screened for appropriateness and general interest. Selected questions received with sufficient notice before the call will be answered as time permits at the end of the call. For further information, contact Vical's Investor Relations department by phone at (858) 646-1127 or by e-mail at ir@vical.com.

      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the company's focus, collaborative partners, product candidates, and developmental status. Risks and uncertainties include whether any product candidates will be shown to be safe and efficacious in clinical trials, the timing of clinical trials, whether Vical or its collaborative partners will seek or gain approval to market any product candidates, the dependence of the company on its collaborative partners, and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

      http://finance.yahoo.com/news/Vical-Announces-News-Release-p…
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      schrieb am 01.11.11 13:00:31
      Beitrag Nr. 172 ()
      wow, sehr gute Zahlen heute :-)
      Avatar
      schrieb am 01.11.11 18:21:09
      Beitrag Nr. 173 ()

      Vical beats by $0.11, beats on revs; updates Allovectin and HSV-2 vaccine programs (VICL)


      2.99 : Reports Q3 (Sep) earnings of $0.22 per share, $0.11 better than the Capital IQ Consensus Estimate of $0.11; revenues rose 1056.5% year/year to $26.6 mln vs the $25 mln consensus, primarily as a result of the recognition of $25.1 million of license revenue for TransVax, Vical's therapeutic vaccine designed to control cytomegalovirus (CMV) reactivation in transplant recipients. The co presented data at an international vaccine conference showing that its Vaxfectin-formulated plasmid DNA vaccines against HSV-2 provided complete protection in guinea pigs against both primary and recurrent HSV-2 disease. The vaccines also significantly reduced genital lesion recurrence and viral shedding as well as latent infection in the central nervous system. These data expanded on previous results from repeated studies in mice showing that the vaccines provided complete protection against lethal challenge, provided sterilizing immunity and inhibited viral counts at both the primary and latent infection sites. These results are among the best ever seen with a herpes vaccine in such a therapeutic model. The company presented encouraging animal data at a National Cancer Institute immunotherapy conference demonstrating a synergistic (more than additive) reduction of tumor growth and a positive trend in survival using a combination of the co's Allovectin immunotherapy with an anti-CTLA-4 antibody.

      http://finance.yahoo.com/marketupdate/inplay#vicl
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      schrieb am 02.11.11 12:23:24
      Beitrag Nr. 174 ()
      Vical to Present at Credit Suisse 2011 Healthcare Conference



      Press Release Source: Vical Incorporated On Wednesday November 2, 2011, 6:30 am

      PHOENIX, Nov. 2, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that the company's President and Chief Executive Officer, Vijay B. Samant, will provide an overview of the company's technologies, development programs, and strategic partnerships at the Credit Suisse 2011 Healthcare Conference (Phoenix, AZ, November 9 - 11; presentation November 9 at 7:30 a.m. MT/9:30 a.m. ET). A webcast of Mr. Samant's presentation will be available live and archived through the Events page in the Investors section of the Vical website at www.vical.com.
      http://finance.yahoo.com/news/Vical-Present-Credit-Suisse-pz…" target="_blank" rel="nofollow ugc noopener">
      http://finance.yahoo.com/news/Vical-Present-Credit-Suisse-pz…
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      schrieb am 02.11.11 17:21:40
      Beitrag Nr. 175 ()
      New Star Analyst Rankings for Vical Incorporated

      StarMine > 02.11.11. Wed 9:44AM EDT


      http://finance.yahoo.com/q/sa?s=vicl
      1 Antwort
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      schrieb am 07.11.11 11:22:45
      Beitrag Nr. 176 ()
      Antwort auf Beitrag Nr.: 42.291.971 von bernie55 am 02.11.11 17:21:40Rare Analyst Calls With Huge Upside in Vical and ......

      November 4, 2011

      Vical Inc. (NASDAQ: VICL) is rarely given huge analyst calls due to what is a small $250 million or so in market cap. The team at Credit Suisse initiated Vical with an “Outperform” rating this morning but more important is its price target of $7.00 per share. This represents more than a 100% move compared to the $3.45 close on Thursday. What was more impressive was the $7.00 price target versus a $3.45 close before, indicating just over 100% upside.

      Credit Suisse noted that Vical’s lead product Allovectin is in a Phase III trial for the treatment of metastatic melanoma but noted that it also has a pipeline of other vaccine product candidates. The firm’s discounted cash flow target is based solely on Allovectin, which the firm noted “makes Vical a high risk investment because Allovectin still needs to successfully complete Phase 3 and the FDA approval process.” The firm went on to note impressive Phase II data with overall survival of chemo-naïve and experienced patients as being 18.8 months. It further noted that the drug did even better in chemo-naïve patients with a median overall survival of 22.5 months versus 11.2 months from Bristol-Myers Squibb Company (NYSE: BMY) Yervoy+DTIC in chemo naïve patients.

      http://biohealthinvestor.com/2011/11/rare-analyst-calls-with…
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      schrieb am 01.12.11 21:02:44
      Beitrag Nr. 177 ()
      neuerdings kursziel 9 $, aber da wird uns die geldgeile UBS wieder in die suppe spucken, wetten?- shorten schon wieder mit 20.000 stück
      Avatar
      schrieb am 02.12.11 09:14:02
      Beitrag Nr. 178 ()
      Global Hunter Securities Initiates Buy, $9 PT on Vical Incorporated

      December 01, 2011 10:56 AM
      Symbols: VICL
      Tags: Global Hunter Securities

      Global Hunter Securities initiates coverage on Vical Inc. (NASDAQ: VICL [FREE Stock Trend Analysis]) with a Buy rating and a target price of $9 per share as the company makes progress on its clinical programs in 2011.

      GHS says, “With the announcement of partnering TransVax development in hematopoietic stem cell transplantation with Astellas, Vical made tremendous progress advancing its clinical programs in 2011.

      Allovectin continues to be the key value driver, which we anticipate will position the company with the leading melanoma therapy and a blockbuster opportunity in the 2013 timeframe.”



      http://www.benzinga.com/analyst-ratings/analyst-color/11/12/…
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      schrieb am 06.12.11 14:10:44
      Beitrag Nr. 179 ()
      UBS shorted - nun gehts erst mal runter - schade
      Avatar
      schrieb am 05.01.12 13:39:05
      Beitrag Nr. 180 ()
      diese pleite UBS shortet alles kurz und klein- wie lange noch?
      Avatar
      schrieb am 05.01.12 23:48:53
      Beitrag Nr. 181 ()
      aha- dilution - schon wieder
      Avatar
      schrieb am 07.01.12 14:38:12
      Beitrag Nr. 182 ()
      Jan. 6, 2012, 11:56 a.m. EST

      Vical slides 12% on stock offering



      By Val Brickates Kennedy

      BOSTON (MarketWatch) -- Shares of Vical Inc. VICL +0.82% slid 12% to $3.75 on Friday after the biotech group announced it plans to sell 13.3 million of its common shares at $3.75 a share, or about 12% below the stock's closing price on Thursday.

      The transaction, which is expected to close around Jan. 11, should gross the company approximately $50 million
      http://www.marketwatch.com/story/vical-slides-12-on-stock-of…" target="_blank" rel="nofollow ugc noopener">
      http://www.marketwatch.com/story/vical-slides-12-on-stock-of…
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      schrieb am 07.01.12 14:44:54
      Beitrag Nr. 183 ()
      Antwort auf Beitrag Nr.: 42.563.582 von bernie55 am 07.01.12 14:38:12Vical Incorporated Prices Public Offering of Common Stock
      GlobeNewswirePress Release: Vical Incorporated – 23 hours ago


      SAN DIEGO, Jan. 6, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced the pricing of an underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $3.75 per share. The gross proceeds to us from this offering are expected to be approximately $50 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering is expected to close on or about January 11, 2012, subject to customary closing conditions.

      Citigroup, Credit Suisse Securities (USA) LLC and Leerink Swann LLC are acting as joint book-running managers and Rodman & Renshaw, LLC is acting as co-manager in the offering.

      Vical has granted the underwriters a 30-day option to purchase up to an aggregate of 2,000,000 additional shares of common stock. Vical anticipates using the net proceeds from the offering for general corporate purposes, including clinical trial expenses, research and development expenses and other working capital.
      http://finance.yahoo.com/news/Vical-Incorporated-Prices-pz-2…" target="_blank" rel="nofollow ugc noopener">
      http://finance.yahoo.com/news/Vical-Incorporated-Prices-pz-2…
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      schrieb am 11.01.12 23:04:14
      Beitrag Nr. 184 ()
      Vical Provides Updates on CMV Vaccine Programs

      SAN DIEGO, Jan. 11, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced the online publication of a new article1 in The Lancet Infectious Diseases detailing results from the company's completed Phase 2 proof-of-concept trial of its TransVax(TM) therapeutic vaccine, which is designed to control cytomegalovirus (CMV) infection or reactivation in transplant recipients. Separately, the company is participating this week in a two-day public workshop jointly sponsored by multiple agencies within the U.S. Department of Health and Human Services (HHS), "The Development and Evaluation of Human Cytomegalovirus Vaccines," in connection with the company's CyMVectin(TM) prophylactic vaccine, which is designed to elicit protective immunity in young women before they become pregnant, thereby protecting the fetus from transmission of CMV during pregnancy.

      About CMV


      CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. While a healthy immune system typically protects an infected person from developing CMV disease, it rarely succeeds in eliminating the infection. Those whose immune systems are not fully functional are at high risk of CMV infection or reactivation, potentially leading to severe illness or death; those at greatest risk include transplant patients and infants born to mothers who first become infected during pregnancy. Vical is pursuing two different vaccine approaches for these distinct market segments.

      TransVax(TM) Therapeutic CMV Vaccine Program


      During the third quarter of 2011, Vical and Astellas Pharma Inc. entered into exclusive worldwide license agreements to develop and commercialize TransVax(TM). Astellas expects to initiate a pivotal, multinational Phase 3 trial of TransVax(TM) for hematopoietic stem cell transplant (HSCT) recipients, and a Phase 2 efficacy trial of TransVax(TM) for solid organ transplant (SOT) recipients, both in the first half of 2012.

      In an editorial commentary2 accompanying the article in The Lancet Infectious Diseases, independent CMV expert Christoph Steininger, MD, of the Medical University of Vienna, said, "... Kharfan-Dabaja and colleagues describe a phase 2, placebo-controlled trial of a therapeutic cytomegalovirus DNA vaccine (TransVax(TM)) for patients undergoing haemopoietic stem-cell transplantation. Occurrence and duration of episodes of cytomegalovirus viraemia were significantly reduced when cytomegalovirus-seropositive patients, who are at highest risk for cytomegalovirus disease, received up to four doses of the vaccine. The results of this study are exciting, particularly in view of the frustrating failures of previous trials."

      TransVax(TM) is a bivalent DNA vaccine encoding the CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) antigens for induction of both cellular and humoral immune responses. TransVax(TM) is formulated with a proprietary poloxamer-based delivery system. TransVax(TM) has received orphan drug designation in the United States for HSCT and SOT recipients.

      CyMVectin(TM) Prophylactic CMV Vaccine Program

      In the CMV workshop, Vical is participating on two panels with other CMV vaccine developers, including Merck, Sanofi, GlaxoSmithKline and Novartis, addressing potential regulatory pathways for prophylactic CMV vaccine development, and specifically addressing potential Phase 3 endpoints for a prophylactic application. The workshop is jointly sponsored by the U.S. Food and Drug Administration (FDA) and its Center for Biologics Evaluation and Research (CBER), the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID), the Centers for Disease Control and Prevention (CDC), and the National Vaccine Program Office (NVPO).

      To prevent infection in females of child-bearing potential, Vical is developing CyMVectin(TM), a prophylactic DNA vaccine encoding the pp65 and gB antigens. The CyMVectin(TM) vaccine is formulated with Vical's Vaxfectin(R) adjuvant in order to enhance antibody and T-cell responses. The FDA has allowed the company's Investigational New Drug (IND) application for a Phase 1 trial of the CyMVectin(TM) vaccine, and Vical is exploring collaborative opportunities for further development and commercialization.

      http://finance.yahoo.com/news/Vical-Provides-Updates-CMV-pz-…
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      schrieb am 20.01.12 18:13:43
      Beitrag Nr. 185 ()
      hier shorted die UBS-mit erfolg - vorerst
      Avatar
      schrieb am 24.01.12 18:36:26
      Beitrag Nr. 186 ()
      mein gott - UBS - du kämpfst gegen windmühlen
      1 Antwort
      Avatar
      schrieb am 25.01.12 18:30:50
      Beitrag Nr. 187 ()
      Antwort auf Beitrag Nr.: 42.640.925 von Kurumba am 24.01.12 18:36:26Immunotherapy Cancer Trials With Key Data Due In 2012


      ....daraus ein kleiner Auszug über VICL.....

      Vical Incorporated (VICL) started 2011 off with more-clearly portrayed phase II data in their Allovectin-7 trial for patients with metastatic melanoma. The most recently completed Phase 2 trial was a single-arm, open-label study in which 127 chemo-refractory or chemo-intolerant subjects were treated with Allovectin-7. There were no treatment-related Grade 3 or 4 adverse effects and no withdrawals from the trial due to patient intolerability. The overall response rate for the 127 patients receiving the high-dose treatment was 11.8%, with 4 complete responders and 11 partial responders. The median duration of response was about 14 months and median survival was nearly 19 months. These data compared favorably against historical controls from other studies in metastatic melanoma and helped provide guidance for the FDA's SPA in their phase III trial.

      Allovectin-7 works by stimulating an immunity response by T lymphocytes (T Cells) to attack tumor cells expressing HLA B7/β2M. The drug not only tentatively destroys the tumor it is injected into via allogeneic anti-tumor response, but it also restores tumor-associated antigen presentation via MHC class 1 and boosts the immune response by the lipid/DNA-induced danger signal (most chemotherapy and radiotherapy actually compromise the patient's immunity system causing additional problems later on). These danger signals are surmised to act by stimulating dendritic cells to mature so that they can present foreign antigens and stimulate T lymphocytes to begin their work at killing the cells. This multi-faceted approach is fairly unique in the immunotherapy drug world in that it is a first-line attack intended to act alone rather than to "clean up" the residual cancer cells left over from or developing after other standards of care have been performed.

      The Phase 3 trial, which started in January 2007, is evaluating Allovectin-7 as a first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. Vical completed enrollment in February 2010 of approximately 390 chemo-naive patients randomized on a 2:1 basis: about 260 for treatment with Allovectin-7 and approximately 130 for treatment with either dacarbazine or temozolomide (current standard of care drugs). The trial protocol allows a maximum two-year treatment and follow-up period for the primary endpoint (response rate at 24 weeks or more after randomization), so the last patients must complete treatment by February 2012.
      Top-line data for the primary endpoint and secondary endpoint (overall survival) should be in Q2 and will be a significant catalyst for the company, whether positive or negative.

      This is a pivotal trial and its potential success can lead directly to a drug application and potential regulatory approval. Not only would the latter provide the company with much needed revenue, it could also validate the drug's approach in attacking many forms of cancer with similar HLA B7/β2M expression making this a huge catalyst for this $245 million market cap biotech.

      In each of these three biotechs, investors must realize and more fully understand the potential marketability of the drugs and platforms. The data coming due in 2012 for each of these drugs could potentially legitimize (or otherwise) not only the drugs' intended indications but also their applications for multiple other indications. With an understanding of this as well as additional research into each company's financials and pipeline depth potential, investors will be able to ascertain the upside potential and downside risk for each.
      http://seekingalpha.com/article/321991-immunotherapy-cancer-…" target="_blank" rel="nofollow ugc noopener">
      http://seekingalpha.com/article/321991-immunotherapy-cancer-…
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      schrieb am 30.01.12 14:29:31
      Beitrag Nr. 188 ()
      Vical Presents Case Study on Successful Design of Allovectin(R) Phase 3 Melanoma Trial

      ASHINGTON, Jan. 30, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) announced today that the company will present a case study of its Allovectin(R) Phase 3 trial at the Phacilitate Cell & Gene Therapy Forum 2012 (Washington -- January 30 - February 1). Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development, is scheduled to present on Monday, January 30, at 2:30 p.m.

      Dr. Rolland's presentation reviews the company's success in designing and conducting its ongoing multinational pivotal Phase 3 melanoma trial through the Special Protocol Assessment process with the U.S. Food and Drug Administration (FDA), and outlines manufacturing and commercialization considerations in support of the possible licensure of Allovectin(R).

      The Phase 3 trial, initiated in January 2007, is evaluating Allovectin(R) as first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. Vical completed enrollment in February 2010 of 390 chemo-naive patients randomized on a 2:1 basis: 260 for treatment with Allovectin(R) and 130 for treatment with physician's choice of either dacarbazine or temozolomide. The company is projecting completion of the Phase 3 trial and release of top-line data in mid-2012.

      Allovectin(R) is a novel gene-based immunotherapeutic with unique mechanisms of action fundamentally different from currently approved treatments. Vical estimates that the worldwide market for Allovectin(R) as a treatment for metastatic melanoma is between $500 million and $1 billion annually, and potential applications for other types of cancer could further expand its total use.

      Because the mechanisms of action for Allovectin(R) are not melanoma-specific, it has the potential to be used in other types of solid tumors. AnGes MG, Inc., has licensed rights to commercialize Allovectin(R) in specified Asian countries, and is primarily interested in developing Allovectin(R) as a treatment for head and neck cancer, which presents a significant unmet medical need in Asia. Vical has retained rights to commercialize Allovectin(R) in North America, Europe and other regions.

      http://finance.yahoo.com/news/Vical-Presents-Case-Study-pz-2…
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      schrieb am 02.02.12 12:57:59
      Beitrag Nr. 189 ()


      Vical Announces News Release and Conference Call Schedule for 2011 Financial Results

      SAN DIEGO, Feb. 2, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that the company will report financial results for the three months and twelve months ended December 31, 2011, before the opening of trading on Wednesday, February 8, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Wednesday, February 8. The call is open on a listen-only basis to any interested parties. The company will provide details on independent and partnered development programs in the conference call and webcast.

      Conference Call

      To listen to the conference call, dial in approximately ten minutes before the scheduled call to (913) 312-1500 (preferred), or (888) 710-4016 (toll-free), and reference confirmation code 5101204. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 5101204. The call also will be available live and archived through the events page at www.vical.com.

      Invited analysts and institutional investors may ask questions during the conference call. Others may submit questions before the call by e-mail addressed to ir@vical.com or by fax to (858) 646-1150. Submitted questions will be screened for appropriateness and general interest. Selected questions received with sufficient notice before the call will be answered as time permits at the end of the call. For further information, contact Vical's Investor Relations department by phone at (858) 646-1127 or by e-mail at ir@vical.com.

      http://www.vical.com/investors/news-releases/News-Release-De…
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      schrieb am 07.02.12 11:50:05
      Beitrag Nr. 190 ()
      läuft gut in den USA
      Avatar
      schrieb am 09.02.12 11:49:32
      Beitrag Nr. 191 ()
      Vical's CEO Discusses Q4 2011 Results - Earnings Call Transcript

      February 8, 2012 |


      ...our revenues for 2011 were $30 million as compared to $8.7 million in 2010...........2011 revenues included $28 million from the upfront payment,

      ........the increase in revenues decrease our net loss for 2011 to $7.3 million or $0.10 per share, compared with a net loss for 2010 of $30.4 million or $0.51 per share.

      .....as a result, our net cash burn for the year was $4 million, and we ended the year with cash and equivalent of $56 million which was at the high end of our guidance.


      http://seekingalpha.com/article/351701-vical-s-ceo-discusses…
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      schrieb am 16.02.12 15:14:59
      Beitrag Nr. 192 ()
      Avatar
      schrieb am 17.02.12 10:17:20
      Beitrag Nr. 193 ()
      Avatar
      schrieb am 18.02.12 14:19:13
      Beitrag Nr. 194 ()
      schon wieder 6 mio shorts
      1 Antwort
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      schrieb am 29.02.12 10:40:29
      Beitrag Nr. 195 ()
      Antwort auf Beitrag Nr.: 42.771.864 von Kurumba am 18.02.12 14:19:13Vical's CEO Hosts at Citi 2012 Global Health Care Conference (Transcript)

      February 28, 2012 |


      http://seekingalpha.com/article/399381-vical-s-ceo-hosts-at-…
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      schrieb am 06.03.12 14:39:42
      Beitrag Nr. 196 ()
      Vical announces initiation of clinical trial for DNA vaccine using Vaxfectin

      Theflyonthewall.comTheflyonthewall.com – Mon, Mar 5, 2012 6:32 AM EST

      Vical announced that the Naval Medical Research Center has initiated a Phase 1 human clinical trial of a tetravalent dengue DNA vaccine formulated with the company's Vaxfectin adjuvant. The trial is based on efficacy data from a nonhuman primate study recently published in the journal Vaccine1. Vical manufactured the vaccine and the adjuvant for both the preclinical and clinical studies, and is providing regulatory and clinical expertise to NMRC for the dengue program. Vical completed three prior Phase 1 trials, with no safety issues and no dose-limiting toxicity, of Vaxfectin-formulated DNA vaccines against H5N1 and H1N1 pandemic influenza.
      http://finance.yahoo.com/news/vical-announces-initiation-cli…" target="_blank" rel="nofollow ugc noopener">
      http://finance.yahoo.com/news/vical-announces-initiation-cli…
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      schrieb am 13.03.12 12:19:33
      Beitrag Nr. 197 ()
      bei 3$ war das tief
      2 Antworten
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      schrieb am 28.03.12 15:27:28
      Beitrag Nr. 198 ()
      Antwort auf Beitrag Nr.: 42.892.892 von Kurumba am 13.03.12 12:19:33Vical announces a novel transmission-blocking malaria DNA vaccine candidate uses its Vaxfectin adjuvant

      (VICL) 3.32 : Co announced that researchers at Ehime University in Japan and their collaborators have developed a Vaxfectin-formulated DNA vaccine candidate with the potential to prevent transmission of malaria. Results of the initial testing, recently published in the journal Vaccine1, demonstrated that the malaria parasite life cycle was interrupted in mosquitoes fed with malaria-infected human red blood cells incubated with serum from vaccinated mice. Vical provided the DNA vaccine plasmid backbone and the adjuvant used in the research.

      http://finance.yahoo.com/marketupdate/inplay#vicl
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      schrieb am 30.03.12 09:04:00
      Beitrag Nr. 199 ()
      Antwort auf Beitrag Nr.: 42.967.468 von bernie55 am 28.03.12 15:27:28

      Vical's Vaxfectin Adjuvant Used In Novel Malaria Vaccine
      March 28, 2012

      Vical (VICL) announced today that researchers at Ehime University in Japan and their collaborators have developed a Vaxfectin-formulated DNA vaccine candidate with the potential to prevent transmission of malaria.

      According to Medicinenet, malaria is an infectious disease caused by a parasite, Plasmodium, which infects red blood cells. Malaria is characterized by cycles of chills, fever, pain and sweating. Historical records suggest malaria has infected humans since the beginning of mankind. Roughly 2 million people die each year worldwide due to Plasmodium infections. The majority are children under the age of five years in sub-Saharan African countries. As astounding as it sounds, there are about 400 million new cases per year worldwide. Most people in the U.S. diagnosed with the disease contract infections outside of the country, usually while living or traveling through an area where malaria is endemic.

      Several factors determine the treatment regime used in any given situation, but it basically boils down to what species of Plasmodium parasite is involved, the clinical situation (child, adult, pregnant), and the susceptibility of the parasite to specific treatments. The latter is a function of the geographic area in which the infection was acquired. But treatment is difficult. Aralen (chloroquine phosphate) usually is the drug of choice, but several malaria strains are resistant to chloroquine. Other protocols may involve the use of such drugs as Vibramycin, Oracea, Adoxa, Atridox, Achromycin, Cleocin and Malarone. Unfortunately, no treatment is universally effective, and the search for a promising drug class continues.

      Enter Vical. The company and researchers at Ehime University in Japan and their collaborators have developed a Vaxfectin-formulated DNA vaccine candidate with the potential to prevent transmission of malaria. Results of the initial testing, recently published in the journal Vaccine1, demonstrated that the malaria parasite life cycle was interrupted in mosquitoes fed with malaria-infected human red blood cells incubated with serum from vaccinated mice. Vical provided the DNA vaccine plasmid backbone and the adjuvant used in the research.

      Here's how the vaccine works. The transmission-blocking DNA vaccine candidate, formulated with Vical's Vaxfectin adjuvant, expresses the Plasmodium vivax malaria parasite protein Pvs230, which is present in both human and mosquito stages of the parasite's life cycle. Anti-Pvs230 antibodies generated by vaccinated mice recognized the Pvs230 protein and interrupted the parasite's development in mosquitoes. The mouse-generated Pvs230 antibodies, incubated with P. vivax-infected human red blood cells and then fed to mosquitoes, statistically reduced the number of parasites and the infection rate in mosquitoes.

      According to the company, this novel transmission-blocking approach could be used to protect a broad segment of the population from widespread malaria outbreaks.

      Technical Analysis


      As seen in the daily chart below (courtesy StockCharts.com), the stock made a double bottom in March just below $3.00, and has since rebounded, breaking through the 50-day moving average on the news of the malaria vaccine discovery. Both the Relative Strength and the MACD are positive. Resistance looms at $3.65, the 200-day moving average.

      On a weekly basis, the stock appears to be trapped in a trading range between the 50- and 200-week moving averages, with resistance at $3.68, close to the 200-day moving average. Relative Strength and the MACD are weak. A close above $3.70 would indicate the start of a new uptrend.



      Additional disclosure: I am long VICL and will not alter my position within 72 hours of the time of publication of this article. Material presented here is for informational purposes only. Consult your financial adviser before making investment decisions. Investing includes risks, including loss of principal.
      http://seekingalpha.com/article/463481-vical-s-vaxfectin-adj…" target="_blank" rel="nofollow ugc noopener">
      http://seekingalpha.com/article/463481-vical-s-vaxfectin-adj…
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      schrieb am 21.04.12 17:36:25
      Beitrag Nr. 200 ()
      hier hat die UBS fette shortgewinne gemacht- jetzt hat sie schwierigkeiten, die aktie wieder auf vordermann zu bringen
      Avatar
      schrieb am 25.04.12 15:51:09
      Beitrag Nr. 201 ()
      Vical Announces News Release and Conference Call Schedule for First Quarter 2012 Financial Results

      SAN DIEGO, April 25, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (VICL - News) today announced that the company will report financial results for the three months ended March 31, 2012, before the opening of trading on Wednesday, May 2, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Wednesday, May 2. The call is open on a listen-only basis to any interested parties. The company will provide details on independent and partnered development programs in the conference call and webcast.

      Conference Call

      To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 325-4933 (preferred), or (877) 718-5107 (toll-free), and reference confirmation code 3816436. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 3816436. The call also will be available live and archived through the events page at www.vical.com.

      Invited analysts and institutional investors may ask questions during the conference call. Others may submit questions before the call by e-mail addressed to ir@vical.com or by fax to (858) 646-1150. Submitted questions will be screened for appropriateness and general interest. Selected questions received with sufficient notice before the call will be answered as time permits at the end of the call. For further information, contact Vical's Investor Relations department by phone at (858) 646-1127 or by e-mail at ir@vical.com.

      http://finance.yahoo.com/news/vical-announces-news-release-c…
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      schrieb am 25.04.12 15:52:49
      Beitrag Nr. 202 ()
      Antwort auf Beitrag Nr.: 43.086.822 von bernie55 am 25.04.12 15:51:09Vical coverage assumed with an Outperform at Credit Suisse

      Target $5.

      http://www.theflyonthewall.com/permalinks/entry.php/VICLid16…" target="_blank" rel="nofollow ugc noopener">
      http://www.theflyonthewall.com/permalinks/entry.php/VICLid16…
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      schrieb am 02.05.12 11:01:31
      Beitrag Nr. 203 ()
      ...vielleicht kommt VICAL auch in den Fokus von Pfizer.....;)


      Pfizer says on lookout for mid-size drug deals

      By Ransdell Pierson

      Tue May 1, 2012 4:24pm EDT

      (Reuters) - Pfizer Inc, which last week agreed to sell its baby formula business for almost $12 billion, is on the hunt for companies with promising new treatments for diabetes, cancer and neurological conditions, and willing to spend $4 billion or more apiece, company Chief Executive Ian Read said.

      http://www.reuters.com/article/2012/05/01/us-pfizer-idUSBRE8…" target="_blank" rel="nofollow ugc noopener">
      http://www.reuters.com/article/2012/05/01/us-pfizer-idUSBRE8…
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      schrieb am 04.05.12 14:42:36
      Beitrag Nr. 204 ()
      Vical Incorporated Stock Upgraded (VICL)


      Vical Incorporated Stock Upgraded (VICL)
      By TheStreet Wire 05/04/12 - 05:00 AM EDT

      NEW YORK (TheStreet) -- Vical Incorporated (Nasdaq:VICL) has been upgraded by TheStreet Ratings from sell to hold.;) The company's strengths can be seen in multiple areas, such as its robust revenue growth, largely solid financial position with reasonable debt levels by most measures and compelling growth in net income.

      However, as a counter to these strengths, we find that the stock has had a generally disappointing performance in the past year.


      Highlights from the ratings report include:

      VICL's very impressive revenue growth greatly exceeded the industry average of 4.5%. Since the same quarter one year prior, revenues leaped by 1665.8%. Growth in the company's revenue appears to have helped boost the earnings per share.

      VICL has no debt to speak of therefore resulting in a debt-to-equity ratio of zero, which we consider to be a relatively favorable sign.

      The company's current return on equity greatly increased when compared to its ROE from the same quarter one year prior. This is a signal of significant strength within the corporation. When compared to other companies in the Biotechnology industry and the overall market, VICAL INC's return on equity has significantly outperformed in comparison with the industry average, but has underperformed when compared to that of the S&P 500.

      VICAL INC reported significant earnings per share improvement in the most recent quarter compared to the same quarter a year ago. The company has demonstrated a pattern of positive earnings per share growth over the past two years. However, we anticipate underperformance relative to this pattern in the coming year. During the past fiscal year, VICAL INC continued to lose money by earning -$0.11 versus -$0.51 in the prior year. For the next year, the market is expecting a contraction of 163.6% in earnings (-$0.29 versus -$0.11).

      VICL has underperformed the S&P 500 Index, declining 18.64% from its price level of one year ago. Looking ahead, other than the push or pull of the broad market, we do not see anything in the company's numbers that may help reverse the decline experienced over the past 12 months. Despite the past decline, the stock is still selling for more than most others in its industry.

      .

      Vical Incorporated engages in the research and development of biopharmaceutical products based on its deoxyribonucleic acid (DNA) delivery technologies for the prevention and treatment of serious or life-threatening diseases. Vical has a market cap of $262 million and is part of the health care sector and drugs industry. Shares are down 29.7% year to date as of the close of trading on Thursday.

      http://www.thestreet.com/story/11521368/1/vical-incorporated…" target="_blank" rel="nofollow ugc noopener">
      http://www.thestreet.com/story/11521368/1/vical-incorporated…
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      schrieb am 08.05.12 21:45:02
      Beitrag Nr. 205 ()
      Vical to Present at Upcoming Investor Conferences

      SAN DIEGO, May 8, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced that the company will provide an overview of its technologies, development programs, and outlook at two upcoming investor conferences.

      Vical will present on Tuesday, May 15, at 10:00 a.m. PDT (1:00 p.m. EDT) at the Bank of America/Merrill Lynch 2012 Health Care Conference (Las Vegas, May 15 -- 17).

      Vical will present on Monday, June 4, at 9:00 a.m. EDT at the Jefferies 2012 Global Health Care Conference (New York, June 4 -- 7).

      A webcast of the company's presentation at the Bank of America/Merrill Lynch conference will be available live and archived through the Events & Presentations page in the Investors section of the Vical website at www.vical.com.
      http://finance.yahoo.com/news/vical-present-upcoming-investo…" target="_blank" rel="nofollow ugc noopener">
      http://finance.yahoo.com/news/vical-present-upcoming-investo…
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      schrieb am 09.05.12 21:30:14
      Beitrag Nr. 206 ()
      Avatar
      schrieb am 18.05.12 13:40:04
      Beitrag Nr. 207 ()
      Vical Updates Herpes Simplex Vaccine Development at ASGCT Conference

      16 May 2012


      PHILADELPHIA, PA, USA I May 16, 2012 I Vical Incorporated (Nasdaq: VICL - News) today announced that results from multiple animal studies with the company's Vaxfectin(R)-formulated plasmid DNA (pDNA) vaccines against herpes simplex virus type 2 (HSV-2) demonstrate proof of concept supporting the company's decision in early 2012 to advance toward clinical testing, which is expected to begin in 2013. Results from completed prophylactic and therapeutic studies in mice and therapeutic studies in guinea pigs included:

      Prophylactic pDNA vaccines encoding HSV-2 glycoprotein D (gD) alone or encoding gD and the HSV-2 tegument proteins UL46 and UL47 provided complete protection from primary and recurrent disease.
      Both prophylactic vaccines significantly reduced viral replication at the primary genital infection site.
      Both prophylactic vaccines significantly reduced detectable HSV-2 infection at the dorsal root ganglia latent site.
      The therapeutic pDNA vaccine encoding gD, UL46 and UL47 significantly reduced the frequency of genital lesion outbreaks in animals with pre-established HSV-2 infections.
      The therapeutic vaccine significantly reduced the frequency of genital viral shedding.

      Sean M. Sullivan, Ph.D., Vical's Executive Director of Pharmaceutical Sciences, is scheduled to present at 3:30 p.m. EDT on Wednesday, May 16, at the 15th Annual Meeting of the American Society of Gene & Cell Therapy, (Philadelphia -- May 16-19). Dr. Sullivan's presentation, "Development of Vaxfectin(R)-formulated HSV-2 Plasmid DNA Vaccines for Prophylactic and Therapeutic Applications," summarizes the previously reported animal study data supporting the advance to human testing.

      HSV-2 is a sexually transmitted virus which is the leading cause of genital herpes. Approximately one out of every six individuals in the United States and an estimated one out of every four worldwide is infected by HSV-2 before age 50. HSV-2 infections are persistent and can result in debilitating genital lesions, as well as periodic virus shedding placing sexual partners at risk. HSV-2 infection also significantly increases the risk of acquiring HIV-1. There is no approved vaccine for HSV-2.


      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      SOURCE: Vical
      Avatar
      schrieb am 22.05.12 15:02:41
      Beitrag Nr. 208 ()
      Vical Announces Publication of Herpes Simplex Vaccine Mouse Study Data

      SAN DIEGO, May 22, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today announced the online publication of a new article1 in The Journal of General Virology detailing results from the company's completed mouse studies with the company's Vaxfectin(R)-formulated plasmid DNA (pDNA) vaccines against herpes simplex virus type 2 (HSV-2). These results, along with previously presented results from guinea pig studies, support the company's decision in early 2012 to advance toward clinical testing, which is expected to begin in 2013.

      HSV-2 is a sexually transmitted virus which is the leading cause of genital herpes. Approximately one out of every six individuals in the United States and an estimated one out of every four worldwide is infected by HSV-2 before age 50. HSV-2 infections are persistent and can result in debilitating genital lesions, as well as periodic virus shedding placing sexual partners at risk. HSV-2 infection also significantly increases the risk of acquiring HIV-1. There is no approved vaccine for HSV-2.
      http://finance.yahoo.com/news/vical-announces-publication-he…" target="_blank" rel="nofollow ugc noopener">
      http://finance.yahoo.com/news/vical-announces-publication-he…
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      schrieb am 23.05.12 10:05:24
      Beitrag Nr. 209 ()
      @Vicalianics

      Gestern wurde in den USA bei niedrigem Volumen der Kurs ganz gewaltig an die Unterstützungslinie von 2,81 USD gedrückt.

      Da die Top-line Resultate der Phase III nach meinem Wissenstand erst im 4.Quartal erwartet werden, wird der Kurs der VICAL Aktie weiterhin großen Schwankungen unterworfen sein.

      Ich bin deshalb seit heute mit meinen restlichen Aktien raus - ich werde die Entwicklung von VICAL aber weiterhin von der Seitenlinie beobachten.

      Allen anderen noch Investierten

      GOOD LUCK

      Grüße bernie55;)
      Avatar
      schrieb am 26.05.12 16:32:15
      Beitrag Nr. 210 ()
      UBS shorted noch immer - diese bank ist unglaublich
      Avatar
      schrieb am 08.08.12 15:18:22
      Beitrag Nr. 211 ()
      Keiner mehr investiert? Sommerloch?
      Gruss reaggy
      Avatar
      schrieb am 08.08.12 21:15:42
      Beitrag Nr. 212 ()
      Avatar
      schrieb am 19.09.12 18:43:03
      Beitrag Nr. 213 ()
      Langsam wird's ja was. Habe aufgestockt, vielleicht melden sich ja paar
      Mitstreiter.
      Gruß reaggy:)
      1 Antwort
      Avatar
      schrieb am 19.09.12 20:28:12
      Beitrag Nr. 214 ()
      Antwort auf Beitrag Nr.: 43.622.595 von reaggy26 am 19.09.12 18:43:03Hallo - bin derzeit nur gelegentlich hier im board - leider etwas wenig Zeit um hier viel mitzulesen - bin vor ein paar Tagen mit einer netten Position bei VICL eingestiegen weil der Deal mit BMY einfach Wogen schlagen muss:D, hab auch hier ´nen Thread dazu eingestellt...

      Einen selbstaktualisierenden Chart findest du da auch drin.

      Die nachhaltigeren Kursanstiege bei VICL finden ja meist immer in deftigen Schüben statt - ich rechne daß wir recht bald die 5$-Marke testen werden.

      ...das Volumen ist in den letzten Tagen auch deutlich über dem Durchschnitt - da wird aktuell nach den guten News eingesammelt, dann folgt ein Upgrade...:lick:
      Avatar
      schrieb am 25.09.12 15:03:57
      Beitrag Nr. 215 ()
      :mad:....wenn die UBS nicht dauernd shorten würde....
      Avatar
      schrieb am 13.08.13 03:11:19
      Beitrag Nr. 216 ()
      - jaja- hier hat mal wieder das Establishment zugeschlagen - dank HERB GREENBERG- allerdings werden manche wach - if A7 did no better than chemo
      Iwould take A7- schreibt ein user
      Avatar
      schrieb am 13.08.13 09:36:07
      Beitrag Nr. 217 ()
      http://www.vical.com/investors/news-releases/News-Release-De…


      Vical Phase 3 Trial of Allovectin® Fails to Meet Efficacy Endpoints

      08/12/2013

      Company Focusing Resources on Infectious Disease Vaccine Programs

      Conference Call and Webcast Today at 8:00 a.m. ET

      SAN DIEGO, Aug. 12, 2013 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced top-line results from a Phase 3 trial of Allovectin® (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, in patients with metastatic melanoma. The 390-subject trial failed to demonstrate a statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization or the secondary endpoint of overall survival. Trial data will be further analyzed and detailed results will be submitted for publication.

      "We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," said Vijay B. Samant, President and Chief Executive Officer of Vical. "Based on this outcome, we are terminating the Allovectin® program and focusing our resources on our infectious disease vaccine programs." Mr. Samant added, "We would like to recognize all of the patients and their families, trial investigators and employees who participated in the conduct of this trial and thank them for their efforts."

      Continuing Programs

      "In the coming weeks, we will make the necessary changes to focus resources on our infectious disease vaccine programs and reduce expenses to conserve cash," said Mr. Samant. The company reported cash and investments of $70 million at June 30, 2013, which it believes is adequate for its anticipated needs at least through the end of 2014. Vical has multiple independent and collaborative infectious disease vaccine programs:

      Astellas Pharma Inc. initiated a multinational 500-patient Phase 3 trial of ASP0113, Vical's investigational therapeutic vaccine designed to control cytomegalovirus (CMV) in transplant recipients, for hematopoietic cell transplant (HCT) recipients in June and expects to initiate a Phase 2 trial of ASP0113 for solid organ transplant (SOT) recipients later this year.
      The company is planning to initiate a Phase 1/2 clinical trial of its Vaxfectin®-formulated therapeutic vaccine against herpes simplex virus type 2 (HSV-2) before the end of 2013.
      The company's Vaxfectin®-formulated CyMVectin™ prophylactic vaccine, designed to prevent CMV infection before and during pregnancy, has completed preclinical development and has an allowed investigational new drug application (IND). Vical is seeking a partner for further development.
      Vical has licensed its proprietary Vaxfectin® adjuvant to Bristol-Myers Squibb Company for use in the production of antibodies, and to Cyvax, Inc., a privately held vaccine development company, for use in malaria vaccines. The company is pursuing additional licensing opportunities for Vaxfectin®.
      Two of the company's licensees have products approved for use in animal health applications:

      In 2005, Vical's licensee Aqua Health, a subsidiary of Novartis Animal Health, received Canadian approval to market its proprietary product, Apex®-IHN, a DNA vaccine to protect farm-raised salmon against infectious hematopoietic necrosis virus (IHNV).
      In 2009, Vical's licensee Merial, now a subsidiary of Sanofi, received approval from the U.S. Department of Agriculture to sell a therapeutic DNA vaccine, ONCEPT®, designed to aid in extending the survival time of dogs with oral melanoma.

      Conference Call

      Vical will conduct a conference call and webcast today, August 12, at 8:00 a.m. Eastern Time, to discuss the trial results and the company's path forward with invited participants. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (913) 312-0657 (preferred) or (888) 233-8128 (toll-free) and reference confirmation code 7850968. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 7850968. The call also will be available live and archived through the events page at www.vical.com. For further information, contact Vical's Investor Relations department by phone at (858) 646-1127 or by e-mail at ir@vical.com.

      About Vical

      Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

      Forward-Looking Statements

      This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include net cash use guidance, as well as anticipated developments in independent and collaborative programs, including the initiation and completion of clinical trials. Risks and uncertainties include whether Vical will effectively focus resources on its infectious disease vaccine programs; whether Vical, Astellas or others will continue development of ASP0113, the HSV-2 vaccine, CyMVectin™, or any other independent or collaborative programs; whether Astellas will initiate the planned Phase 2 trial of ASP0113 for SOT recipients later this year, if at all; whether Vical or others will initiate a Phase 1/2 clinical trial of the HSV-2 vaccine in the second half of 2013, if at all; whether Vical will identify and obtain any additional product development opportunities; whether any product candidates will be shown to be safe and efficacious in clinical trials; the timing of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

      CONTACT: Investors
      Vical Incorporated
      Alan R. Engbring
      +1-858-646-1127
      ir@vical.com
      www.vical.com

      Media
      W2O Group
      Susan Neath
      +1-212-301-7182
      Avatar
      schrieb am 29.06.14 17:09:13
      Beitrag Nr. 218 ()
      Noch einer an Bord?


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